G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. The study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and dose-finding portion (Part 1), and a randomized portion (Part 2). Both parts were to include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients were planned to be enrolled in the study.
Checked against the public recordLast updated May 6, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- G1 Therapeutics, Inc.
- Interventions being studied
- Drug: G1T38; Drug: Osimertinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity * For Part 2, EGFR T790M mutation-positive tumor status * Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range * For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 * For Part 2, measurable disease as defined by RECIST, Version 1.1 * ECOG performance status 0 to 1 * Adequate organ function Exclusion Criteria: * Prior treatment with EGFR TKI within 9 days of first study dose * For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC * For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI * For Part 2, prior chemotherapy for advanced NSCLC * Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose * Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow * Prior hematopoietic stem cell or bone marrow transplantation
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Beverly Hills Cancer CenterBeverly Hills, California
- UCLA Medical Center, Division of Hematology/Oncology/Clinical Research UnitSanta Monica, California
- St Joseph Heritage HealthcareSanta Rosa, California
- Sylvester Comprehensive Cancer Center/University of Miami Miller School of Medicine Fox Building, Suite 200 GMiami, Florida
- Mofitt Cancer CenterTampa, Florida
- Univ. of Michigan HospitalsAnn Arbor, Michigan
- Virginia Cancer SpecialistsFairfax, Virginia
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 6, 2023. Always confirm current availability with the study team.