Clinical Trial

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.
Protocol Amendment History 1 change
notable Enrollment increased: 251 -> 345 participants 2026-05-23
Trial Details
NCT Number NCT06043817
Lead Sponsor Pierre Fabre Medicament
Conditions Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
Enrollment 345 participants
Start Date 2023-09-26
Primary Completion 2029-12-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22