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Study identifier: NCT06043817 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-Small Cell Lung Cancer · NSCLC · EGFR/HER2 Exon 20 Insertion Mutation  ·  Sponsor: Pierre Fabre Medicament

PhasePhase 1/Phase 2
Planned participants345
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Adele De MASSON, clinical devlopment director, MD, PhD  ·  33 772344916  ·  PFL721_medical.team@pierre-fabre.com

Always discuss trial participation with your own doctor first.

Locations (24)

City of HopeDuarte, California, United StatesRecruiting
City of HopeHuntington Beach, California, United StatesRecruiting
City of HopeIrvine, California, United StatesRecruiting
Levine Cancer Institute - CharlotteCharlotte, North Carolina, United StatesRecruiting
Thomas Jefferson University Research FacilityPhiladelphia, Pennsylvania, United StatesRecruiting
SCRI Oncology Partners - PPDSNashville, Tennessee, United StatesRecruiting
University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
University of Utah - Huntsman Cancer Institute - PPDSSalt Lake City, Utah, United StatesRecruiting
NEXT VirginiaFairfax, Virginia, United StatesRecruiting
EDOG Institut de Cancerologie de l'Ouest - PPDSSaint-Herblain, Loire-Atlantique, FranceRecruiting
Institut Claudius Regaud - PPDSToulouse, FranceRecruiting
Gustave RoussyVillejuif, FranceRecruiting

+ 12 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06043817