NCT06043817 is a Phase 1, PHASE2 clinical trial of STX-721/PFL-721 (Escalated) in Non-Small Cell Lung Cancer, sponsored by Pierre Fabre Medicament.

Who is sponsoring NCT06043817?

NCT06043817 is sponsored by Pierre Fabre Medicament.

What drugs are being tested in NCT06043817?

Interventions in NCT06043817: STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels), STX-721/PFL-721 (RP2D).

What condition does NCT06043817 study?

NCT06043817 studies Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation.

Is NCT06043817 still recruiting?

NCT06043817 is currently recruiting now. Last updated 20 February 2026.

Last reviewed 2026-02-20 · How we verify

NCT06043817

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 now Phase 1, PHASE2 Last updated 20 February 2026

What this trial tests

Phase 1, PHASE2 trial testing STX-721/PFL-721 (Escalated) in Non-Small Cell Lung Cancer in 251 participants. Currently enrolling.

Timeline

26 September 2023

Primary endpoint
1 December 2029

1 December 2029

Quick facts

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	251
Start date	26 September 2023
Primary completion	1 December 2029
Estimated completion	1 December 2029
Sites	24 locations across France, Netherlands, Taiwan, Germany, South Korea, United States, Spain

Drugs / interventions tested

STX-721/PFL-721 (Escalated) — full drug profile →
STX-721/PFL-721 (3 dose levels) — full drug profile →
STX-721/PFL-721 (RP2D) — full drug profile →

Conditions studied

Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
NSCLC — all drugs for NSCLC →
EGFR/HER2 Exon 20 Insertion Mutation — all drugs for EGFR/HER2 Exon 20 Insertion Mutation →

Sponsor

Pierre Fabre Medicament — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer or NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

STX-721, a Covalent EGFR/HER2 Exon 20 Inhibitor, Utilizes Exon 20-Mutant Dynamic Protein States and Achieves Unique Mutant Selectivity Across Human Cancer Models.
Pagliarini RA, Henderson JA, Milgram BC, Borrelli DR, et al · · 2025 · cited 3× · PMID 40465424 · DOI 10.1158/1078-0432.ccr-24-3833
Discovery of STX-721, a Covalent, Potent, and Highly Mutant-Selective EGFR/HER2 Exon20 Insertion Inhibitor for the Treatment of Non-Small Cell Lung Cancer.
Milgram BC, Borrelli DR, Brooijmans N, Henderson JA, et al · · 2025 · cited 3× · PMID 39824516 · DOI 10.1021/acs.jmedchem.4c02377
The current landscape, advancements, and prospects in the treatment of patients with EGFR exon 20 insertion mutations warrant scientific elucidation.
Man X, Sun X, Chen C, Xiang Y, et al · · 2024 · cited 2× · PMID 38919530 · DOI 10.3389/fonc.2024.1367204

Verify or expand the search:

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC · recruiting
NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting

Other Pierre Fabre Medicament trials

Trials by the same sponsor.

NCT06690489 — An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients · completed
NCT06669117 — FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations · Phase 1, PHASE2 · recruiting
NCT06688370 — The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study · terminated
NCT07096206 — Characteristics and Impacts of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED) in Boys: An Observational Internationa · active not recruiting
NCT06623773 — Study on Structum® in Adult Patients With Osteoarthritis (TRUST) · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06043817 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pierre Fabre Medicament
Last refreshed: 20 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06043817.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing