OncoMatch/Clinical Trials/NCT06567015
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
Is NCT06567015 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies STX-241 for non-small cell lung cancer (nsclc).
Treatment: STX-241 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
EGFR-mutant (ex19del or L858R mutations)
Required: EGFR l858r
EGFR-mutant (ex19del or L858R mutations)
Required: EGFR c797x
Presence of C797X 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.
Excluded: EGFR t790m
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.
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: third-generation EGFR TKI
Disease progression on a 3rd generation EGFR TKI-based therapy (administered as monotherapy or in combination) received at any prior line of treatment. / 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.
Cannot have received: targeted therapy for actionable alterations (ALK, BRAF, MET, NTRK, ROS1, HER2)
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. / Participants candidate for targeted therapies available to them such as, but not limited to: ALK, BRAF, MET (ex14 mutation and amplification), NTRK, ROS1, HER2 (mutations and amplification) as identified by local testing performed after progression to 3rd generation EGFR TKI-based therapy.
Cannot have received: first- or second-generation EGFR TKI
Participants who received 1st or 2nd generation EGFR TKIs.
Cannot have received: platinum-based chemotherapy
Exception: participant with rapid progressive disease eligible to receive a platinum-based chemotherapy
Participant with rapid progressive disease eligible to receive a platinum-based chemotherapy.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L; Hemoglobin ≥ 90 g/L.
Kidney function
Estimated glomerular filtration rate (GFR) ≥ 50 mL/min by CKD-EPI equation
Liver function
Serum total bilirubin ≤ 1.5 x ULN or ≤ 3.0 × ULN for participants with documented Gilbert's syndrome. ALT and AST ≤ 3.0 x ULN. If the participant has liver metastases, AST and ALT ≤5 × ULN.
Cardiac function
Mean QTcF ≤ 470 msec for women and ≤ 450 msec for men and no history of long QT syndrome or risk factors for torsade de pointe. LVEF ≥ 50%. Systolic BP < 150 mmHg and diastolic BP < 100 mmHg.
Adequate organ function as defined below: ANC ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L; Hemoglobin ≥ 90 g/L. Serum total bilirubin ≤ 1.5 x ULN or ≤ 3.0 × ULN for participants with documented Gilbert's syndrome. ALT and AST ≤ 3.0 x ULN. If the participant has liver metastases, AST and ALT ≤5 × ULN. Estimated GFR ≥ 50 mL/min by CKD-EPI equation. Adequate cardiac function as defined below: Mean QTcF ≤ 470 msec for women and ≤ 450 msec for men and no history of long QT syndrome or risk factors for torsade de pointe. LVEF ≥ 50%. Systolic BP < 150 mmHg and diastolic BP < 100 mmHg.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) · Nashville, Tennessee
- Oncology Consultants (OC) - Texas Medical Center - Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06567015 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior targeted therapy for actionable alterations (ALK, BRAF, MET, NTRK, ROS1, HER2), first- or second-generation EGFR TKI, platinum-based chemotherapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR c797x is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR t790m is an exclusion criterion.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages