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

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ClinicalTrials.gov Identifier: NCT04005716
Recruitment Status : Active, not recruiting
First Posted : July 2, 2019
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

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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 30, 2022
Estimated Study Completion Date : October 2023


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.




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)



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005716


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Ying Cheng, Professor Jilin Provincial Tumor Hospital
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04005716    
Other Study ID Numbers: BGB-A317-312
CTR20190511 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Carboplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action