Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination With Osimertinib in Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)

Keywords

Carcinoma, Non-Small-Cell Lung Lung Cancer Non-small Cell Lung Cancer CDK 4/6 Inhibitor EGFR-Positive EGFR Mutation- Positive T790M EGFR Mutant lerociclib Lung Neoplasms Osimertinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Beverly Hills Cancer Center
    Beverly Hills California 90211 United States
  • St Joseph Heritage Healthcare
    Santa Rosa California 95403 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
G1 Therapeutics, Inc.
ID
NCT03455829
Phase
Phase 1/2
Study Type
Interventional
Last Updated