RecruitingPhase I/IIEN originalLung cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Potwierdzony zaawansowany lub przerzutowy rak płuca (etap IIIB/C lub IV) z mutacją genu EGFR
  • •Choroba pogorszyła się mimo leczenia lekami trzeciej generacji (takimi jak osimertinib)
  • •Obecność mutacji C797X w genie (wykazanej w badaniu krwi lub tkanki)
  • •Co najmniej jeden widoczny guz do zmierzenia
  • •Dobry stan ogólny (skala ECOG 0-1)
  • •Prawidłowe wyniki badań krwi: wystarczająca liczba białych krwinek, płytek i hemoglobiny

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 2, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (18)

Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

Nashville, United States

Oncology Consultants (OC) - Texas Medical Center - Cancer Center

Houston, United States

Shanghai East Hospital, Tongji University

Shanghai, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Centre Léon Bérard

Lyon, France

CHU Hôpital de la Timone

Marseille, France

Institut de Cancérologie de l'Ouest (ICO) - René Gauducheau

Saint-Herblain, France

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Netherlands Cancer Institute

Amsterdam, Netherlands

Hospital Quironsalud Barcelona

Barcelona, Spain

Vall d'Hebron Institut d'Oncologia

Barcelona, Spain

Hospital San Pedro

Logroño, Spain

Hospital Universitario La Paz

Madrid, Spain

Centro Intergral Oncologico Clara Campal (CIOCC) (START Madrid)

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/3/2026.

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