At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Unequivocally confirmed diagnosis of SCLC by histology or cytology
- ✓At least 1 unirradiated, measurable target lesion by RECIST v1.1
- ✓ECOG performance status 0-2
- ✕Prior chemotherapy for extensive-stage SCLC
- ✕Symptomatic brain metastases requiring immediate radiation or steroids
- ✕Uncontrolled ischemic heart disease or congestive heart failure
- ✕Stroke or cerebrovascular accident within 6 months prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin
In Brief
A Phase 2 clinical trial evaluating Carboplatin, Placebo, and 2 other interventions for Small Cell Lung Cancer. Completed, enrolled 122 participants across 40 sites in 7 countries.
Detailed Summary
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.