G1T38-03 Tagrisso

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)

Objective

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.

Study Arms

  • Experimental: Part 1: G1T38 + Osimertinib
  • Experimental: Part 2: G1T38 + Osimertinib
  • Active Comparator: Part 2: Osimertinib

Eligibility

  • 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

NCT ID

NCT03455829