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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 6, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.