Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04902885

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

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04902885
Study type Interventional
Source Jiangsu Simcere Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date May 25, 2021
Completion date December 31, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04985851 - To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS. N/A
Completed NCT01987232 - Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Subjects With Previously Untreated Extensive Stage Small-cell Lung Cancer Phase 1/Phase 2
Not yet recruiting NCT06427369 - An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer Phase 1
Recruiting NCT06223711 - Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC Phase 2
Completed NCT05002868 - Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors Phase 1
Recruiting NCT04790253 - PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) N/A
Withdrawn NCT05572476 - Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer Phase 2
Recruiting NCT05874401 - Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Phase 4
Not yet recruiting NCT06008353 - A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Untreated Extensive Stage-Small Cell Lung Cancer Receiving Durvalumab Combined With Platinum-Etoposide in (ES-SCLC) in Brazil
Recruiting NCT04947774 - Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer
Active, not recruiting NCT05280470 - Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Phase 2
Recruiting NCT05765825 - Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC Phase 2
Recruiting NCT05761977 - Durvalumab in Combination With Standard Chemotherapy of Patients With Extensive Stage Small Cell Lung Cancer
Active, not recruiting NCT05092412 - Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC Phase 2
Not yet recruiting NCT06306560 - A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC. Phase 2
Recruiting NCT06211036 - Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab Phase 3
Recruiting NCT04894591 - To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
Not yet recruiting NCT06437509 - A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer Phase 2
Not yet recruiting NCT06449209 - Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy Phase 2
Completed NCT04878016 - A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC Phase 3