RecruitingNon-small Cell Lung Cancer (NSCLC)
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Pierre Fabre Medicament
You may qualify if…
- ✓ 1. Signed and dated informed consent for participation in the trial obtained according to International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), and national/local regulations.
- ✓ 2. Male or female ≥ 18 years of age at the time of signing informed consent but at least of legal age in their country.
- ✓ 3. Histological confirmation of locally advanced or metastatic, EGFR-mutant (ex19del or L858R mutations) non-small cell lung cancer (NSCLC) Stage IIIB/C or IV (AJCC 8th edition) not eligible for curative intent surgery or chemoradiation.
- ✓ 4. Part 1 Disease progression on a 3rd generation EGFR TKI-based therapy (administered as monotherapy or in combination) received at any prior line of treatment.
- ✓ Part 2: Disease progression after a 3rd generation EGFR TKI-based therapy (administered as monotherapy or in combination) given as first or second line of systemic anti-cancer therapy and no more than 2 prior lines of systemic anti-cancer therapy.
- ✓ 5. Tumor mutation profile:
- ✓ Part 1 (backfilling component): Presence of C797X and absence of T790M mutations documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on treatment with 3rd generation EGFR TKI.
- ✓ Part 2: Presence of C79X mutation documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on a 3rd generation EGFR TKI-based therapy.
You may not qualify if…
- ✕ 1. Part 1: Participants candidate for targeted therapies available to them (such as but not limited to therapies targeting ALK, BRAF, MET, NTRK, ROS1) as identified by local testing performed after progression to the last line of systemic therapy.
- ✕ Part 2: Participants candidate for targeted therapies available to them such as, but not limited to: ALK, BRAF, MET (ex14 mutation and amplification), NTRK, ROSI, HER2 (mutations and amplification) as identified by local testing performed after progression to 3rd generation EGFR TKI-based therapy.
- ✕ 2. Part 2: Participants who received 1st or 2nd generation EGFR TKIs.
- ✕ 3. Participant with rapid progressive disease eligible to receive a platinum-based chemotherapy.
- ✕ 4. Participant unable ingest or digest tablets. This can be caused by any impaired gastrointestinal function or disease, such as for example: ulcerative diseases, malabsorption syndrome, small bowel resection, ileus, etc. or any condition causing uncontrolled nausea, vomiting or diarrhea.
- ✕ 5. History of a primary malignancy other than NSCLC with the exception of:
- ✕ Participants with a previous malignancy that completed all curative anticancer treatment at least 2 years before signing informed consent and with no evidence of residual disease from the prior malignancy at screening.
- ✕ Malignancies with a negligible risk of metastasis or death (i.e. 5-year overall survival rate \> 90%) that are adequately treated - Examples include, but are not limited to, completely resected basal cell carcinoma and squamous cell carcinoma of skin, melanoma in situ, curatively treated prostate cancer, breast cancer and early gastric cancer cured by endoscopic mucosal resection or endoscopic submucosal dissection.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06567015 · last updated 2026-09-02