Overview

Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin Combined With Etoposide or Topotecan

Status:
Recruiting

Trial end date:
2023-03-15

Target enrollment:

Participant gender:

Summary

A Randomized, double-blind, placebo-controlled, multi-center Phase 3 study evaluating efficacy, safety and pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin combined with Etoposide or Topotecan The study consists of 2 parts: Part 1: safety run-in and pharmacokinetics evaluation of 12 ES-SCLC patients (6 each for first line and second/third line ES-SCLC patients); Part 2: randomized, double-blind, placebo-controlled efficacy confirmation study of 80 ES-SCLC patients (stratified by first line and second/third line ES-SCLC, ECOG PS [0-1 vs 2] and brain metastases. The study includes screening period, treatment period, safety follow-up and survival follow-up.

Phase:

Phase 3

Details

Lead Sponsor:

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborator:

G1 Therapeutics, Inc.

Treatments:

Carboplatin
Etoposide
Topotecan