Lung Cancer Clinical Trial
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
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.
Full Description
Part 2, the Phase 2 part of the study, was not conducted due to changes in corporate strategy. There were no safety signals identified in Phase 1/Part 1 that would have precluded the conduct of Part 2. As a result, 30 out of the planned 144 patients were enrolled.
All tumor assessments were conducted by the Investigators or site radiologist. In order to reduce the burden to the patients, data of overall survival (OS) were no longer required (since 29 January 2020). No OS analysis was conducted for Part 1 due to limited data in Part 1.
PK data for Cohorts 4 (150 BID) and 5 (200 BID) were not analyzed as they were deemed unnecessary, as the PK data from Cohorts 1-3 were sufficient to achieve the secondary study objective of assessing the effect of osimertinib on PK parameters of G1T38.
Eligibility 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
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There are 8 Locations for this study
Beverly Hills California, 90211, United States
Santa Monica California, 90404, United States
Santa Rosa California, 95403, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Ann Arbor Michigan, 48109, United States
Fairfax Virginia, 22301, United States
Milwaukee Wisconsin, 53226, United States
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