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出境医 / 临床实验 / Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

Study Description
Brief Summary:

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer.

The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（Cisplatin or Carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer.

Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-Blind, Placebo-controlled Study of Platinum(Cisplatin or Carboplatin) Plus Etoposide With or Without Toripalimab as First Line Therapy in Patients With ExtensiveStage Small Cell Lung Cancer
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : June 18, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: TORIPALIMAB Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Active Comparator: Chemotherapy Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Outcome Measures
Primary Outcome Measures :
  1. PFS (Progression Free Survival) by investigator [ Time Frame: Approximately 2 years ]
    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

  2. Overall suvival (OS) [ Time Frame: Approximately 2.8 years ]
    Overall suvival (OS)


Secondary Outcome Measures :
  1. PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board） [ Time Frame: Approximately 2 years ]
    PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;

  2. ORR (Objective Response Rate) [ Time Frame: Approximately 2 years ]
    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;

  3. DOR (Duration of Response) [ Time Frame: Approximately 2 years ]
    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;

  4. DCR (Disease of Response) [ Time Frame: Approximately 2 years ]
    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;

  5. TTR (Time to Response) [ Time Frame: Approximately 2 years ]
    Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;

  6. OS (Overall Survival) rate [ Time Frame: Approximately 2 years ]
    OS rates at 1 and 2 years

  7. Incidence of AEs/SAEs [ Time Frame: Approximately 2 years ]
    Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0

  8. PFS (Progression Free Survival) Rate [ Time Frame: Approximately 1year ]
    PFS rates at 6-month（inestigators and BICR） and at 1-year


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:

  1. ≥18 years , male or female;
  2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
  3. ECOG PS 0~1;
  4. No prior treatment or immunocheckpoint inhibitors for ES-SCLC;
  5. Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC；
  6. Patients with asymptomatic brain metastases who have received previous treatment
  7. Has provided tumor tissue samples
  8. Estimated survival time ≥8 weeks;
  9. There is at least one measurable lesion that conforms to RECIST criteria v1.1.For lesions that have received previous radiation therapy, the lesion can only be included in the measurable lesion if the disease progression is clear after radiotherapy and the lesion is not the only measurable lesion.
  10. Before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol.
  11. Has adequate hematologic and end organ function

Exclusion Criteria:

  1. Prior systemtic treatment for ES-SCLC;
  2. Prior treatment with any CD137 agnist or immunocheckpoint inhibitors.
  3. Subjects with active or untreated central nervous system (CNS) tumor metastasis;
  4. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
  5. Cancerous meningitis;
  6. Uncontrolled or symptomatic hypercalcemia;
  7. Other malignant tumors within 5 years prior to the first dose of study treatment
  8. Subjects with any active, known or suspected autoimmune disease;
  9. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis .
  10. Subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery;
  11. Significant cardiovascular disease, such as New York Heart Assoc
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ying Cheng, prof +86431-8587-1902 jl.cheng@163.com

Locations
Layout table for location information
China
Ying Cheng Recruiting
Chang chun, China
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE July 23, 2019
Estimated Primary Completion Date July 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • PFS (Progression Free Survival) by investigator [ Time Frame: Approximately 2 years ]
    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)
  • Overall suvival (OS) [ Time Frame: Approximately 2.8 years ]
    Overall suvival (OS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board） [ Time Frame: Approximately 2 years ]
    PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;
  • ORR (Objective Response Rate) [ Time Frame: Approximately 2 years ]
    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;
  • DOR (Duration of Response) [ Time Frame: Approximately 2 years ]
    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;
  • DCR (Disease of Response) [ Time Frame: Approximately 2 years ]
    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;
  • TTR (Time to Response) [ Time Frame: Approximately 2 years ]
    Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;
  • OS (Overall Survival) rate [ Time Frame: Approximately 2 years ]
    OS rates at 1 and 2 years
  • Incidence of AEs/SAEs [ Time Frame: Approximately 2 years ]
    Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0
  • PFS (Progression Free Survival) Rate [ Time Frame: Approximately 1year ]
    PFS rates at 6-month（inestigators and BICR） and at 1-year
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer
Official Title  ICMJE A Phase III Randomized, Double-Blind, Placebo-controlled Study of Platinum(Cisplatin or Carboplatin) Plus Etoposide With or Without Toripalimab as First Line Therapy in Patients With ExtensiveStage Small Cell Lung Cancer
Brief Summary

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer.

The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（Cisplatin or Carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer.

Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Study Arms  ICMJE
  • Experimental: TORIPALIMAB
    Intervention: Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
  • Active Comparator: Chemotherapy
    Intervention: Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 18, 2022
Estimated Primary Completion Date July 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥18 years , male or female;
  2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
  3. ECOG PS 0~1;
  4. No prior treatment or immunocheckpoint inhibitors for ES-SCLC;
  5. Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC；
  6. Patients with asymptomatic brain metastases who have received previous treatment
  7. Has provided tumor tissue samples
  8. Estimated survival time ≥8 weeks;
  9. There is at least one measurable lesion that conforms to RECIST criteria v1.1.For lesions that have received previous radiation therapy, the lesion can only be included in the measurable lesion if the disease progression is clear after radiotherapy and the lesion is not the only measurable lesion.
  10. Before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol.
  11. Has adequate hematologic and end organ function

Exclusion Criteria:

  1. Prior systemtic treatment for ES-SCLC;
  2. Prior treatment with any CD137 agnist or immunocheckpoint inhibitors.
  3. Subjects with active or untreated central nervous system (CNS) tumor metastasis;
  4. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
  5. Cancerous meningitis;
  6. Uncontrolled or symptomatic hypercalcemia;
  7. Other malignant tumors within 5 years prior to the first dose of study treatment
  8. Subjects with any active, known or suspected autoimmune disease;
  9. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis .
  10. Subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery;
  11. Significant cardiovascular disease, such as New York Heart Assoc
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ying Cheng, prof +86431-8587-1902 jl.cheng@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012606
Other Study ID Numbers  ICMJE JS001-028-III-SCLC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Junshi Bioscience Co., Ltd.
Study Sponsor  ICMJE Shanghai Junshi Bioscience Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Junshi Bioscience Co., Ltd.
Verification Date September 2020

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

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