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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005716
• Other study ID #: BGB-A317-312
• Secondary ID: CTR20190511
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2019
• Est. completion date: December 29, 2023

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: December 29, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline until death from any cause (up to approximately 51 months)
Secondary	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	Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months)
Secondary	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	Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 29 months)
Secondary	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	up to approximately 29 months
Secondary	Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events		up to approximately 51 months
Secondary	Percentage of patients with clinically meaningful changes post baseline		up to approximately 29
Secondary	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		up to approximately 29 months
Secondary	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)	Baseline until PD or death, whichever occurs first (up to approximately 29 months)