NCT03041311

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC

Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: G1 Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100 patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.

Detailed description

The posted results represent the final results from Study G1T28-05, a Phase 2 study of carboplatin, etoposide, and atezolizumab with or without trilaciclib (G1T28) in patients with untreated extensive-stage small cell lung cancer (SCLC). The final myelopreservation efficacy results are from database lock 1 (data cut-off \[DCO\] 17 Aug 2018). The final anti-tumor efficacy data (BOR, DOR, PFS) are from a second database lock 2 (DCO 28 June 2019) that occurred to support the trilaciclib New Drug Application (NDA). Final overall survival and safety data are reported from the final study database lock (DCO 11 Dec 2020, last patient last visit date of 29 October 2020). Please note the last patient last visit date description above which is recorded as the study completion date. Following the last patient last visit, the final database lock occurred a few weeks later which accounts for the discrepancy between the study completion date and the reported assessment time frames.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Trilaciclib	Trilaciclib IV
DRUG	Placebo	Placebo IV
DRUG	Carboplatin	Carboplatin IV
DRUG	Etoposide	Etoposide IV
DRUG	Atezolizumab	Atezolizumab IV

Timeline

• Start date: 2017-06-29
• Primary completion: 2018-08-17
• Completion: 2020-10-29
• First posted: 2017-02-02
• Last updated: 2025-09-25
• Results posted: 2022-05-06

Locations

45 sites across 7 countries: United States, Bulgaria, Estonia, France, Latvia, Spain, Ukraine

Regulatory

• FDA-regulated drug study