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

Primary Purpose

Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tislelizumab, Carboplatin /Cisplatin, Etoposide
Carboplatin / Cisplatin, Etoposide
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of Anhui Medical University
  • Beijing Hospital
  • China-Japan Friendship Hospital
  • Chinese PLA General Hospital
  • The Third Hospital of Peking University
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  • Name:Peking University International Hospital
  • Beijing Cancer Hospital
  • Army Special Medical Center (Daping Hospital)
  • Fujian Cancer Hospital
  • Fujian Medical University Union Hospital
  • First Affiliated Hospital of Xiamen University
  • First Hospital of Lanzhou University
  • Cancer Center of Guangzhou Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Guangdong Provincial People's Hospital
  • Affiliated Hospital of Guilin Medical University
  • Guangxi Zhuang Autonomous Region People's Hospital
  • Affiliated Tumor Hospital of Guangxi Medical University
  • Affiliated Tumor Hospital of Harbin Medical University
  • Henan Cancer Hospital
  • First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital Tongji Medical College Huazhong University of Sciences and Technology
  • Union Hospital Tongji Medical College Huazhong University of Sciences and Technology
  • The Central Hospital Wuhan
  • Hunan Cancer Hospital
  • Xiangya Hospital, Central South University
  • Changsha Central Hospital
  • General Hospital of Nanjing Military Command
  • Nanjing Chest Hospital
  • The First Affiliated Hospital of Soochow University
  • Jilin Cancer Hospital
  • The First Affiliated Hospital of China Medical University
  • Liaoning Cancer Hospital
  • Jinan Central Hospital
  • Shandong Cancer Hospital
  • Affiliated hospital of Qingdao University
  • Yantai Yuhuangding Hospital
  • Shanghai Chest Hospital
  • Shanghai Pulmonary Hospital
  • Shannxi Provincial Cancer Hospital
  • The First Affiliated Hospital of Xi 'an Jiaotong University
  • West China Hospital · Sichuan University
  • Sichuan Cancer Hospital
  • Tianjin Cancer Hospital
  • General Hospital of Tianjin Medical University
  • Affiliated Tumor Hospital of Xinjiang Medical University
  • Yunnan Cancer Hospital
  • The First Affiliated Hospital of Zhejiang University Medical College
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tislelizumab plus etoposide and platinum

Placebo plus etoposide and platinum

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS)
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

Objective Response Rate (ORR)
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)
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)
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
Percentage of patients with clinically meaningful changes post baseline
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
Progression Free Survival (PFS)
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)

Full Information

First Posted
July 1, 2019
Last Updated
May 24, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT04005716
Brief Title
Study of Platinum Plus Etoposide With or Without BGB-A317 in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tislelizumab plus etoposide and platinum
Arm Type
Experimental
Arm Title
Placebo plus etoposide and platinum
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tislelizumab, Carboplatin /Cisplatin, Etoposide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin / Cisplatin, Etoposide
Intervention Description
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 Measure Information:
Title
Overall Survival (OS)
Description
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)
Time Frame
Baseline until death from any cause (up to approximately 51 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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
Time Frame
Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months)
Title
Duration Of Response (DOR)
Description
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
Time Frame
Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months)
Title
Disease Control Rate (DCR)
Description
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
Time Frame
up to approximately 29 months
Title
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
Title
Percentage of patients with clinically meaningful changes post baseline
Time Frame
up to approximately 29
Title
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
Title
Progression Free Survival (PFS)
Description
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)
Time Frame
Baseline until PD or death, whichever occurs first (up to approximately 29 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age≥18 years old, male or female, signed Informed Consent Form (ICF). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Histologically or cytologically confirmed ES-SCLC No prior systemic treatment for ES-SCLC Adequate hematologic and end organ function Key Exclusion Criteria: Active leptomeningeal disease or uncontrolled, untreated brain metastasis; 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; Was administered a live vaccine ≤ 4 weeks before randomization; Active autoimmune diseases or history of autoimmune diseases that may relapse Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization; With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases; 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; Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection; Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization; Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, Professor
Organizational Affiliation
Jilin Provincial Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
The Third Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Name:Peking University International Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102206
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Army Special Medical Center (Daping Hospital)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510059
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510059
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Name
Guangxi Zhuang Autonomous Region People's Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
168600
Country
China
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Affiliated Tumor Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Sciences and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Sciences and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
The Central Hospital Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410018
Country
China
Facility Name
General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Nanjing Chest Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Affiliated hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shannxi Provincial Cancer Hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710061
Country
China
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital · Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33509647
Citation
Wu J, Zhang A, Li L, Liu S, Yang F, Yang R. Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer. Clin Ther. 2021 Mar;43(3):582-593.e2. doi: 10.1016/j.clinthera.2020.12.017. Epub 2021 Jan 25.
Results Reference
derived

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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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