At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Trilaciclib, carboplatin, etoposide，or Topotecan and placebo, carboplatin, etoposide，or Topotecan for Extensive-stage Small-cell Lung Cancer. Completed, enrolled 95 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Trilaciclib plus carboplatin, etoposide for first line patients ;Trilaciclib plus Topotecan for second or third line patients
placebo plus carboplatin, etoposide for first line patients ;placebo plus Topotecan for second or third line patients