Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
NCT03041311 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2025-09-25
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.
Conditions
Interventions
- DRUG
-
Trilaciclib
Trilaciclib IV
- DRUG
-
Placebo IV
- DRUG
-
Carboplatin IV
- DRUG
-
Etoposide
Etoposide IV
- DRUG
-
Atezolizumab IV
Sponsors & Collaborators
-
Roche-Genentech
collaborator INDUSTRY -
G1 Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Contact · G1 Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-29
- Primary Completion
- 2018-08-17
- Completion
- 2020-10-29
- FDA Drug
- Yes
Countries
- United States
- Bulgaria
- Estonia
- France
- Latvia
- Spain
- Ukraine
Study Locations
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