Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs (NCT06567015)
Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) — Nashville, Tennessee
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) — Nashville, Tennessee
- Oncology Consultants (OC) - Texas Medical Center - Cancer Center — Houston, Texas
- Shanghai East Hospital, Tongji University — Shanghai,
- Tianjin Medical University Cancer Institute and Hospital — Tianjin,
- Centre Léon Bérard — Lyon,
- CHU Hôpital de la Timone — Marseille,
- Institut de Cancérologie de l'Ouest (ICO) - René Gauducheau — Saint-Herblain,
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse,
- Gustave Roussy — Villejuif,
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden,
- Netherlands Cancer Institute — Amsterdam,
- Vall d'Hebron Institut d'Oncologia — Barcelona,
- Hospital Universitario La Paz — Madrid,
- Centro Intergral Oncologico Clara Campal (CIOCC) (START Madrid) — Madrid,
- National Taiwan University Hospital — Taipei,
- Taipei Veterans General Hospital — Taipei,
📞 Contact the Study Coordinator
Phone: +33 (0)7 87 29 60 13
Email: isabelle.klauck@pierre-fabre.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Non-small Cell Lung Cancer (NSCLC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.