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NCT03041311 · ClinicalTrials.gov registry record · Phase 2
Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
A Phase 2 study of Small-cell Lung Cancer, sponsored by G1 Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT03041311: Completed Phase 2 study of Small-cell Lung Cancer, sponsored by G1 Therapeutics.
NCT03041311 is a Phase 2 study of Small-cell Lung Cancer that has completed, run by G1 Therapeutics. The registered enrollment target is 107 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03041311, a Phase 2 study of Small-cell Lung Cancer, has completed, sponsored by G1 Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of \<0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10⁹/L and (2) no other ANC values \<0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Etoposide
- DRUG Trilaciclib
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- St. Jude Heritage Healthcare - Fullerton
- Loma Linda University - Loma Linda
- UCLA Medical Center - Santa Monica Hematology And Oncology - Santa Monica
- Redwood Regional Medical Group (RRMG) - Fountain Grove - Santa Rosa
- Singing River Health System - Whittier
Georgia
- Piedmont Cancer Institute - Atlanta
- Northside Hospital - Georgia Cancer Specialists - Atlanta
Missouri
- St. Louis Cancer Care, LLP, North County - Bridgeton
- The Alvin J. Siteman Cancer Center - Center for Advanced Med - St Louis
Texas
- Valley Cancer Associates - Harlingen
- Millennium Oncology - Houston
Illinois
- Joliet Oncology-Hematology Associates - Joliet
Indiana
- Horizon Oncology Center - Lafayette
Louisiana
- Ochsner Clinic Foundation - New Orleans
New Jersey
- Summit Medical Group, P.A. - Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2020-10-29 |
| Phase | Phase 2 |
What the finished NCT03041311 record still lists
NCT03041311 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03041311 names 20 study sites across 12 states, led by California, Georgia, Missouri.
Frequently Asked Questions
What is clinical trial NCT03041311 about?
NCT03041311 is a clinical study titled "Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC". 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 ...
What is the current status of trial NCT03041311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2017-06-29. Estimated completion is 2020-10-29.
What conditions does trial NCT03041311 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT03041311?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Atezolizumab (DRUG), Etoposide (DRUG), Trilaciclib (DRUG).
Who is sponsoring clinical trial NCT03041311?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03041311 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03041311's enrollment target sits among peer trials
107 35th of 79 higher than 45 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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