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出境医 / 临床实验 / Study of Platinum Plus Etoposide With or Without BGB-A317 in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

Study of Platinum Plus Etoposide With or Without BGB-A317 in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

Study Description
Brief Summary:
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide (Arm A) and placebo + cisplatin or carboplatin + etoposide (Arm B) as first-line treatment in approximately 455 participants who have previously untreated extensive-stage small cell lung cancer (ES-SCLC)

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide Drug: Carboplatin / Cisplatin, Etoposide Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : October 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: tislelizumab plus etoposide and platinum Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide
Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
Active Comparator: Placebo plus etoposide and platinum Drug: Carboplatin / Cisplatin, Etoposide
Placebo Q3W in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin AUC 5 IV Q3W) for 4 cycles. Then maintenance consists of Placebo Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
Outcome Measures
Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 51 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the intent to treat Analysis Set as measured by overall survival (OS)


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1

  2. Duration Of Response (DOR) [ Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1

  3. Disease Control Rate (DCR) [ Time Frame: up to approximately 29 months ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1

  4. Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: up to approximately 51 months ]
  5. Percentage of patients with clinically meaningful changes post baseline [ Time Frame: up to approximately 29 ]
  6. Time to deterioration (TTD), defined as the time from randomization to the first occurrence of worsening scores confirmed at the following visit or death from any cause [ Time Frame: up to approximately 29 months ]
  7. Progression Free Survival (PFS) [ Time Frame: Baseline until PD or death, whichever occurs first (up to approximately 29 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)


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

Key Inclusion Criteria:

  1. Age≥18 years old, male or female, signed Informed Consent Form (ICF).
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. Histologically or cytologically confirmed ES-SCLC
  4. No prior systemic treatment for ES-SCLC
  5. Adequate hematologic and end organ function

Key Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
  2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
  3. Was administered a live vaccine ≤ 4 weeks before randomization;
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse
  5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
  6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
  7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection;
  8. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
  9. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
  10. Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations
Show Show 49 study locations
Sponsors and Collaborators
BeiGene
Investigators
Layout table for investigator information
Principal Investigator: Ying Cheng, Professor Jilin Provincial Tumor Hospital
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2020) 		Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 51 months) ]
To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the intent to treat Analysis Set as measured by overall survival (OS)
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Progression Free Survival (PFS) [ Time Frame: up to 2.5 years ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
  • Overall Survival (OS) [ Time Frame: up to 3.5 years ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by overall survival (OS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Objective Response Rate (ORR) [ Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
  • Duration Of Response (DOR) [ Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
  • Disease Control Rate (DCR) [ Time Frame: up to approximately 29 months ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
  • Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: up to approximately 51 months ]
  • Percentage of patients with clinically meaningful changes post baseline [ Time Frame: up to approximately 29 ]
  • Time to deterioration (TTD), defined as the time from randomization to the first occurrence of worsening scores confirmed at the following visit or death from any cause [ Time Frame: up to approximately 29 months ]
  • Progression Free Survival (PFS) [ Time Frame: Baseline until PD or death, whichever occurs first (up to approximately 29 months) ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Objective Response Rate (ORR) [ Time Frame: up to 2.5 years ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
  • Duration Of Response (DOR) [ Time Frame: up to 2.5 years ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
  • Disease Control Rate (DCR) [ Time Frame: up to 2.5 years ]
    To evaluate and compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide compared with placebo + cisplatin or carboplatin + etoposide in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
  • Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: up to 2.5 years ]
  • Time to true deterioration (TTD) in patient reported lung cancer symptoms [ Time Frame: up to 2.5 years ]
    health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ LC13) as presented in patient-reported outcomes Scale construct including to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis; each item with range of maximum scores 4 as worse outcome and minimum scores 1 as higher values represent a better
  • Time to true deterioration (TTD) in patient reported HRQoL domains [ Time Frame: up to 2.5 years ]
    health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Core 30 (EORTC QLQ-C30) as presented in patient-reported Outcomes Scale construct including to assess Global health status/QoL with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better; Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning, Fatigue, Nausea and vomiting, Pain Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea and Financial difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent a better.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Platinum Plus Etoposide With or Without BGB-A317 in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Brief Summary This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide (Arm A) and placebo + cisplatin or carboplatin + etoposide (Arm B) as first-line treatment in approximately 455 participants who have previously untreated extensive-stage small cell lung cancer (ES-SCLC)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide
    Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
  • Drug: Carboplatin / Cisplatin, Etoposide
    Placebo Q3W in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin AUC 5 IV Q3W) for 4 cycles. Then maintenance consists of Placebo Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
Study Arms  ICMJE
  • Experimental: tislelizumab plus etoposide and platinum
    Intervention: Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide
  • Active Comparator: Placebo plus etoposide and platinum
    Intervention: Drug: Carboplatin / Cisplatin, Etoposide
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
Actual Enrollment  ICMJE
 (submitted: June 8, 2021) 		457
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		364
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Age≥18 years old, male or female, signed Informed Consent Form (ICF).
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. Histologically or cytologically confirmed ES-SCLC
  4. No prior systemic treatment for ES-SCLC
  5. Adequate hematologic and end organ function

Key Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
  2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
  3. Was administered a live vaccine ≤ 4 weeks before randomization;
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse
  5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
  6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
  7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection;
  8. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
  9. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
  10. Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005716
Other Study ID Numbers  ICMJE BGB-A317-312
CTR20190511 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
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
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ying Cheng, Professor Jilin Provincial Tumor Hospital
PRS Account BeiGene
Verification Date June 2021

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

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