Clinical trialNCT06567015RecruitingPhase 1/PHASE2Interventional

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

SponsorPierre Fabre MedicamentEnrollment171Non-small Cell Lung Cancer (NSCLC)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

China

Shanghai East Hospital, Tongji University
Shanghai, China
Caicun Zhou, Prof.
Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Huang Dingzhi, Prof.
Recruiting

France

Centre Léon Bérard
Lyon, France
Aurelie Swalduz, Dr.
Recruiting
Chu Hôpital de la Timone
Marseille, France
Pascale Tomasini, Dr.
Recruiting
Institut de Cancérologie de L'Ouest (ico) - René Gauducheau
Saint-Herblain, France
Sandrine Hiret, Dr.
Recruiting
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, France
Julien Mazieres, Prof.
Recruiting
Gustave Roussy
Villejuif, France
David Planchard, Prof.
Recruiting

Germany

Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Martin Wermke, Prof.
Recruiting

Netherlands

Netherlands Cancer Institute
Amsterdam, Netherlands
Gerrina Ruiter, MD PhD.
Recruiting

Spain

Vall D'Hebron Institut D'Oncologia
Barcelona, Spain
Enriqueta Felip Font, MD PhD.
Recruiting
Centro Intergral Oncologico Clara Campal (ciocc) (start Madrid)
Madrid, Spain
Ramon Yarza, Dr.
Recruiting
Hospital Universitario la Paz
Madrid, Spain
Javier de Castro Carpeno, Dr.
Recruiting

Taiwan

National Taiwan University Hospital
Taipei, Taiwan
Chi Chi Lin, Dr
Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan
Yung-Hung Luo, Dr.
Recruiting

United States

Sarah Cannon Research Institute (scri) (the Scri Oncology Research Consortium)
Nashville, Tennessee, United States
Melissa Johnson, Dr.
Recruiting
Oncology Consultants (oc) - Texas Medical Center - Cancer Center
Houston, Texas, United States
Julio Peguero, Dr
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

3-(3-Chloro-2-methoxyanilino)-7-(2-methoxyethyl)-2-(2-methylpyrimidin-4-yl)-1,5-dihydropyrrolo[3,2-c]pyridin-4-one →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Sept 2024
Primary completion: 20 Nov 2027
Completion: 31 Jul 2030
Last update posted: 22 May 2026
Registered enrollment: 171
Registry id: NCT06567015

Cross-registrations

EU-CTR / CTIS (EudraCT)2023-510203-21-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.