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

NCT04005716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2025-02-28

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Tislelizumab

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

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.

DRUG

Carboplatin

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.

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2023-04-19
Completion
2023-12-29

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04005716 on ClinicalTrials.gov