G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is 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 is an open-label design, consists of 2 parts: safety, pharmacokinetic, and dose-finding portion (Part 1), and randomized 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, 144 patients will be enrolled in the study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G1 Therapeutics, Inc.
• Treatments: Osimertinib

Criteria

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