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A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:
A Phase III, Randomized，Double-blind Placebo-controlled Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-stage Small Cell Lung Cancer

Clinical Trial Summary

This is a randomized, Phase III, multicenter, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of ZKAB001 in combination with carboplatin + etoposide compared with treatment with placebo + carboplatin + etoposide in patients who have ES-SCLC and are untreated for their extensive-stage disease.

Clinical Trial Description

This study is a randomized, double-blind, placebo-controlled multicenter III study. Eligible patients will randomly enter the trial group or control group at 1:1, that is, ZKAB001+ carboplatin + etoposide or placebo + carboplatin + etoposide, with a treatment cycle every 3 weeks. There are 4 cycles of chemotherapy. Stratification factors included gender (male / female), PS score (0/1) and brain metastasis (yes / no). The study included screening period, treatment period (subjects received study treatment until confirmed disease progression, or intolerable toxic reaction, or reached the maximum medication cycle of 2 years, or the subject voluntarily requested the end of the study treatment) and follow-up period (including safety follow-up and survival follow-up). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04878016
Study type Interventional
Source Lee's Pharmaceutical Limited
Contact
Status Completed
Phase Phase 3
Start date July 15, 2021
Completion date October 13, 2023
View Details
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