Clinical Trial

Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs

Study acronym: STX-241 FIH
Recruiting Phase 1/2
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Summary
The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safety profile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK) exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241/PFL-241, a mutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, in participants with locally advanced or metastatic NSCLC that progressed during or following third generation EGFR TKI such as osimertinib due to C797X double acquired (secondary) mutations.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2024-08-19; most recent amendment 2026-05-20.
Status change: Not Yet Recruiting → Recruiting 2024-10-03
Trial Details
NCT Number NCT06567015
Lead Sponsor Pierre Fabre Medicament
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 171 participants
Start Date 2024-09-17
Primary Completion 2027-11-20 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-22