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Study of Platinum Plus Etopos...

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

Last Updated: 2025-02-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2023-12-29

Brief Summary

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This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

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Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A: Tislelizumab + Chemotherapy

Participants received tislelizumab in combination with either cisplatin or carboplatin (at the investigator's discretion) and etoposide during the induction phase, administered every 3 weeks for 4 cycles. Upon completion of the induction phase, participants transitioned to maintenance therapy with tislelizumab only, administered once every 3 weeks.

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

200 mg administered intravenously on Day 1 of each 21-day cycle

Cisplatin

Intervention Type DRUG

75 mg/m² was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of two hours. Treatment with cisplatin was discontinued starting in Cycle 5 and beyond.

Carboplatin

Intervention Type DRUG

An area under the curve (AUC) of 5 mg/mL/min was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of 15 to 60 minutes. Treatment with carboplatin was discontinued starting in Cycle 5 and beyond.

Etoposide

Intervention Type DRUG

100 mg/m² was administered intravenously from Day 1 to Day 3 of each 21-day cycle, infused over a duration of 60 minutes. Treatment with etoposide was discontinued starting in Cycle 5 and beyond.

Arm B: Placebo + Chemotherapy

Participants received a placebo in combination with either cisplatin or carboplatin (at the investigator's discretion) and etoposide during the induction phase, given every 3 weeks for 4 cycles. Upon completion of the induction phase, participants transitioned to maintenance therapy with placebo only, administered once every 3 weeks.

Group Type PLACEBO_COMPARATOR

Cisplatin

Intervention Type DRUG

75 mg/m² was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of two hours. Treatment with cisplatin was discontinued starting in Cycle 5 and beyond.

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

100 mg/m² was administered intravenously from Day 1 to Day 3 of each 21-day cycle, infused over a duration of 60 minutes. Treatment with etoposide was discontinued starting in Cycle 5 and beyond.

Placebo

Intervention Type DRUG

200 mg was administered intravenously on Day 1 of each 21-day cycle to match tislelizumab.

Interventions

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Tislelizumab

200 mg administered intravenously on Day 1 of each 21-day cycle

Intervention Type DRUG

Cisplatin

75 mg/m² was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of two hours. Treatment with cisplatin was discontinued starting in Cycle 5 and beyond.

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Etoposide

100 mg/m² was administered intravenously from Day 1 to Day 3 of each 21-day cycle, infused over a duration of 60 minutes. Treatment with etoposide was discontinued starting in Cycle 5 and beyond.

Intervention Type DRUG

Placebo

200 mg was administered intravenously on Day 1 of each 21-day cycle to match tislelizumab.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Study Director

Locations

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