美国癌症、全身、血液 Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)-出境医

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出境医 / 临床实验 / Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

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Study Description

Brief Summary:

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

Condition or disease	Intervention/treatment	Phase
Carcinoma, Non-squamous Non-small-cell Lung	Biological: Pembrolizumab Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin Drug: Olaparib	Phase 3

Detailed Description:

This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus pemetrexed plus platinum (carboplatin or cisplatin). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance pemetrexed. In the Maintenance Phase, participants receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance pemetrexed until progressive disease (PD), intolerable toxicities, or physician decision.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	792 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer
Actual Study Start Date :	June 28, 2019
Estimated Primary Completion Date :	August 13, 2024
Estimated Study Completion Date :	December 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21-day cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until progressive disease, physician decision or intolerable toxicity.	Biological: Pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA® Drug: Pemetrexed IV infusion Other Name: ALIMTA® Drug: Carboplatin IV infusion Other Name: PARAPLATIN® Drug: Cisplatin IV infusion Other Names: PLATINOL® PLATINOL®-AQ Drug: Olaparib Tablets Other Name: LYNPARZA®
Active Comparator: Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21 day-cycle for up to 31 cycles PLUS maintenance pemetrexed IV 500 mg/m^2 on Day 1 of each 21-day cycle. In the Maintenance Phase, the participant continues to receive maintenance pemetrexed until progressive disease, physician decision or intolerable toxicity.	Biological: Pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA® Drug: Pemetrexed IV infusion Other Name: ALIMTA® Drug: Carboplatin IV infusion Other Name: PARAPLATIN® Drug: Cisplatin IV infusion Other Names: PLATINOL® PLATINOL®-AQ

Arm

Intervention/treatment

Experimental: Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib

For the Induction Phase, participants receive 4 cycles:

If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.

For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21-day cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until progressive disease, physician decision or intolerable toxicity.

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475
KEYTRUDA®

Drug: Pemetrexed

IV infusion

Other Name: ALIMTA®

Drug: Carboplatin

IV infusion

Other Name: PARAPLATIN®

Drug: Cisplatin

IV infusion

Other Names:

PLATINOL®
PLATINOL®-AQ

Drug: Olaparib

Tablets

Other Name: LYNPARZA®

Active Comparator: Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21 day-cycle for up to 31 cycles PLUS maintenance pemetrexed IV 500 mg/m^2 on Day 1 of each 21-day cycle. In the Maintenance Phase, the participant continues to receive maintenance pemetrexed until progressive disease, physician decision or intolerable toxicity.

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475
KEYTRUDA®

Drug: Pemetrexed

IV infusion

Other Name: ALIMTA®

Drug: Carboplatin

IV infusion

Other Name: PARAPLATIN®

Drug: Cisplatin

IV infusion

Other Names:

PLATINOL®
PLATINOL®-AQ

Outcome Measures

Primary Outcome Measures :

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 3 years ]
Progression-free survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
Overall survival is the time from the date of randomization to death due to any cause.

Secondary Outcome Measures :

Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQ-LC13 cough (Item 1) scale score.
Time to True Deterioration (TTD) in EORTC (QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
Have stage IV nonsquamous NSCLC.
Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
Have measurable disease based on RECIST 1.1.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a life expectancy of at least 3 months.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Has not completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Contacts and Locations

Locations

Show 178 study locations

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United States, Alabama
Alabama Oncology Bruno Cancer Center ( Site 0001)
Birmingham, Alabama, United States, 35205
Northwest Alabama Cancer Center, PC ( Site 0002)
Muscle Shoals, Alabama, United States, 35661
United States, California
Disney Family Cancer Center ( Site 0005)
Burbank, California, United States, 91505
United States, Florida
Boca Raton Regional Hospital ( Site 0018)
Boca Raton, Florida, United States, 33486
Mid-Florida Cancer Centers ( Site 0022)
Orange City, Florida, United States, 32763
Moffitt Cancer Center ( Site 0024)
Tampa, Florida, United States, 33612
United States, Georgia
Columbus Regional Research Institute ( Site 0098)
Columbus, Georgia, United States, 31904
United States, Illinois
Mount Sinai Hospital Medical Center ( Site 0032)
Chicago, Illinois, United States, 60608
Oncology of Northshore ( Site 0033)
Rolling Meadows, Illinois, United States, 60008
United States, Indiana
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)
Merrillville, Indiana, United States, 46410
United States, Maryland
Medstar Good Samaritan Hospital ( Site 0040)
Baltimore, Maryland, United States, 21239
United States, Michigan
Barbara Ann Karmanos Cancer Institute ( Site 0041)
Detroit, Michigan, United States, 48201
United States, Mississippi
Hattiesburg Clinic ( Site 0045)
Hattiesburg, Mississippi, United States, 39401
United States, Montana
Frontier Oncology ( Site 0080)
Billings, Montana, United States, 59102
Bozeman Health Deaconness Cancer Center ( Site 0046)
Bozeman, Montana, United States, 59715
United States, North Carolina
Waverly Hematology Oncology ( Site 0081)
Cary, North Carolina, United States, 27518
United States, Tennessee
Thompson Cancer Survival Center ( Site 2812)
Knoxville, Tennessee, United States, 37804
University of Tennessee Medical Center Knoxville ( Site 0060)
Knoxville, Tennessee, United States, 37920
United States, Texas
Renovatio Clinical ( Site 0062)
The Woodlands, Texas, United States, 77380
United States, Washington
Cancer Care Northwest ( Site 0071)
Spokane Valley, Washington, United States, 99216
Argentina
Hospital Italiano Regional del Sur ( Site 0509)
Bahia Blanca, Buenos Aires, Argentina, B8001HXM
Hospital Britanico de Buenos Aires ( Site 0500)
Buenos Aires, Caba, Argentina, C1280AEB
Instituto Medico Rio Cuarto ( Site 0501)
Rio Cuarto, Cordoba, Argentina, X5800AEV
Centro Oncológico de Rosario ( Site 0507)
Rosario, Santa Fe, Argentina, Rosario
Centro Medico San Roque ( Site 0506)
San Miguel de Tucuman, Tucuman, Argentina, T4000IAK
Hospital Italiano de Buenos Aires ( Site 0511)
Buenos Aires, Argentina, C1199ABB
Clínica Universitaria Reina Fabiola ( Site 0505)
Cordoba, Argentina
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
Santa Fe, Argentina, S3000AOL
Australia, New South Wales
Liverpool Hospital ( Site 1201)
Liverpool, New South Wales, Australia, 2170
Southern Medical Day Care Centre ( Site 1200)
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Townsville General Hospital ( Site 1202)
Townsville, Queensland, Australia, 4814
Australia, Victoria
Monash Cancer Centre ( Site 1205)
Clayton, Victoria, Australia, 3168
Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
Linz, Oberosterreich, Austria, 4020
Klinikum Wels-Grieskirchen ( Site 1304)
Wels, Oberosterreich, Austria, 4600
Innsbruck LKH ( Site 1302)
Innsbruck, Tirol, Austria, 6020
Social Medical Center - Otto Wagner Hospital ( Site 1301)
Vienna, Wien, Austria, 1145
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
Wien, Austria, 1210
Brazil
Hospital Sao Rafael ( Site 0212)
Salvador, Bahia, Brazil, 41253-190
Instituto do Cancer do Ceara ( Site 0201)
Fortaleza, Ceara, Brazil, 60430-230
Oncologica do Brasil ( Site 0210)
Belem, Para, Brazil, 66053-000
Hospital Tacchini ( Site 0208)
Bento Goncalves, Rio Grande Do Sul, Brazil, 95700-000
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
Saint Gallen Instituto de Oncologia ( Site 0206)
Santa Cruz do Sul, Rio Grande Do Sul, Brazil, 96810-110
YNOVA Pesquisa Clinica ( Site 0215)
Florianopolis, Santa Catarina, Brazil, 88020-210
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)
Itajai, Santa Catarina, Brazil, 88301-220
Centro de Hematologia e Oncologia ( Site 0205)
Joinville, Santa Catarina, Brazil, 89201-260
Hospital de Base de Sao Jose de Rio Preto ( Site 0204)
Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
Rio de Janeiro, Brazil, 20230-130
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
Sao Paulo, Brazil, 01246-000
Hospital Paulistano - Amil Clinical Research ( Site 0207)
Sao Paulo, Brazil, 01321-001
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0214)
Sao Paulo, Brazil, 01321-001
Canada, British Columbia
Lions Gate Hospital ( Site 0106)
North Vancouver, British Columbia, Canada, V7L 2L7
BC Cancer - Victoria ( Site 0109)
Victoria, British Columbia, Canada, V8R 6V5
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre ( Site 0107)
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Grand River Hospital ( Site 0117)
Kitchener, Ontario, Canada, N2G 1G3
Stronach Regional Cancer Centre ( Site 0101)
Newmarket, Ontario, Canada, L3Y 2P9
Health Sciences North Research Institute ( Site 0115)
Sudbury, Ontario, Canada, P3E 5J1
Canada, Quebec
CISSS de la Monteregie-Centre ( Site 0114)
Greenfield Park, Quebec, Canada, J4V 2H1
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)
Montreal, Quebec, Canada, H2X 0C1
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
Montreal, Quebec, Canada, H3T 1M5
Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)
Rimouski, Quebec, Canada, G5L 5T1
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
Sherbrooke, Quebec, Canada, J1H 5N4
Colombia
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
Medellin, Antioquia, Colombia, 050030
Clinica de la Costa Ltda. ( Site 0608)
Barranquilla, Atlantico, Colombia, 080020
Administradora Country S.A. ( Site 0603)
Bogota, Distrito Capital De Bogota, Colombia, 110221
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
Bogota, Distrito Capital De Bogota, Colombia, 110311
France
Centre Hospitalier De Chauny ( Site 1411)
Chauny, Aisne, France, 02300
CHU Caen ( Site 1406)
Caen, Calvados, France, 14033
CHU Angers ( Site 1405)
Angers, Maine-et-Loire, France, 49100
Institut De Cancerologie De Lorraine ( Site 1409)
Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54519
Hopital Robert Schuman ( Site 1402)
Vantoux, Moselle, France, 57070
Centre Jean Perrin ( Site 1407)
Clermont Ferrand, Puy-de-Dome, France, 63011
Centre Hospitalier de Pau ( Site 1412)
Pau, Pyrenees-Atlantiques, France, 64000
CHU de Rouen ( Site 1403)
Rouen, Seine-Maritime, France, 76000
Hopital d'Instruction des Armees Begin ( Site 1413)
Saint-Mande, Val-de-Marne, France, 94163
Germany
Studienzentrum Aschaffenburg ( Site 1525)
Aschaffenburg, Bayern, Germany, 63739
Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)
Muenchen, Bayern, Germany, 81925
Klinikum der LMU ( Site 1500)
Munich, Bayern, Germany, 80336
Universitaetsklinikum Regensburg ( Site 1512)
Regensburg, Bayern, Germany, 93053
Klinikum Wuerzburg Mitte gGmbH ( Site 1509)
Wuerzburg, Bayern, Germany, 97074
Universitaetsklinikum Frankfurt ( Site 1513)
Frankfurt, Hessen, Germany, 60590
Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)
Immenhausen, Hessen, Germany, 34376
Universitaetsmedizin Goettingen ( Site 1507)
Goettingen, Niedersachsen, Germany, 37075
Universitaetsklinikum Bonn ( Site 1524)
Bonn, Nordrhein-Westfalen, Germany, 53127
Kliniken Essen Mitte ( Site 1517)
Essen, Nordrhein-Westfalen, Germany, 45136
InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)
Koblenz, Rheinland-Pfalz, Germany, 56068
Helios Klinikum Erfurt GmbH ( Site 1502)
Erfurt, Thuringen, Germany, 99089
Katholisches Marienkrankenhaus gGmbH ( Site 1522)
Hamburg, Germany, 22087
Japan
National Hospital Organization Nagoya Medical Center ( Site 0806)
Nagoya, Aichi, Japan, 460-0001
Aichi Cancer Center Hospital ( Site 0803)
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East ( Site 0801)
Kashiwa, Chiba, Japan, 277-8577
Kanazawa University Hospital ( Site 0811)
Kanazawa, Ishikawa, Japan, 920-8641
Kanagawa Cancer Center ( Site 0807)
Yokohama, Kanagawa, Japan, 241-8515
Sendai Kousei Hospital ( Site 0812)
Sendai, Miyagi, Japan, 980-0873
Kansai Medical University Hospital ( Site 0804)
Hirakata, Osaka, Japan, 573-1191
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
Sakai, Osaka, Japan, 591-8555
Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
Sunto-gun, Shizuoka, Japan, 411-8777
National Hospital Organization Kyushu Medical Center ( Site 0805)
Fukuoka, Japan, 810-8563
Niigata Cancer Center Hospital ( Site 0808)

Tracking Information

First Submitted Date ^ICMJE

June 3, 2019

First Posted Date ^ICMJE

June 6, 2019

Last Update Posted Date

May 18, 2021

Actual Study Start Date ^ICMJE

June 28, 2019

Estimated Primary Completion Date

August 13, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 3 years ]
Progression-free survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
Overall survival is the time from the date of randomization to death due to any cause.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQ-LC13 cough (Item 1) scale score.
Time to True Deterioration (TTD) in EORTC (QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.

Original Secondary Outcome Measures ^ICMJE

Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQ-LC13 cough (Item 1) scale score.
Time to True Deterioration (TTD) in EORTC (QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

Official Title ^ICMJE

A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer

Brief Summary

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Non-squamous Non-small-cell Lung

Intervention ^ICMJE

Biological: Pembrolizumab
IV infusion
Other Names:
- MK-3475
- KEYTRUDA®
Drug: Pemetrexed
IV infusion

Other Name: ALIMTA®
Drug: Carboplatin
IV infusion

Other Name: PARAPLATIN®
Drug: Cisplatin
IV infusion
Other Names:
- PLATINOL®
- PLATINOL®-AQ
Drug: Olaparib
Tablets

Other Name: LYNPARZA®

Study Arms ^ICMJE

Experimental: Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4).

If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.

For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21-day cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until progressive disease, physician decision or intolerable toxicity.
Interventions:
- Biological: Pembrolizumab
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Olaparib
Active Comparator: Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21 day-cycle for up to 31 cycles PLUS maintenance pemetrexed IV 500 mg/m^2 on Day 1 of each 21-day cycle. In the Maintenance Phase, the participant continues to receive maintenance pemetrexed until progressive disease, physician decision or intolerable toxicity.
Interventions:
- Biological: Pembrolizumab
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

792

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 30, 2024

Estimated Primary Completion Date

August 13, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
Have stage IV nonsquamous NSCLC.
Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
Have measurable disease based on RECIST 1.1.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a life expectancy of at least 3 months.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Has not completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Argentina, Australia, Austria, Brazil, Canada, Colombia, France, Germany, Japan, Korea, Republic of, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03976323

Other Study ID Numbers ^ICMJE

7339-006
MK-7339-006 ( Other Identifier: Merck Protocol Number )
2018-004720-11 ( EudraCT Number )
KEYLYNK-006 ( Other Identifier: Merck )
194895 ( Registry Identifier: JAPIC-CTI )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:	http://engagezone.msd.com/ds_documentation.php

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Merck Sharp & Dohme Corp.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

May 2021

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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克利夫兰诊所
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约翰霍普金斯医院
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麻省总医院
美国最佳医院荣誉榜第4名
密歇根大学医院
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倉敷中央医院
日本综合排名第1名
順天堂医院
日本综合排名第2名
藤田医科大学医院（原藤田保健大学医院)
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北里大学医院
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東京医科大学医院
日本综合排名第5名

4006 776 356

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Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

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