OncoMatch/Clinical Trials/NCT06043817
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
Is NCT06043817 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including STX-721/PFL-721 (Escalated) and STX-721/PFL-721 (3 dose levels) for non-small cell lung cancer.
Treatment: STX-721/PFL-721 (Escalated) · STX-721/PFL-721 (3 dose levels) · STX-721/PFL-721 (RP2D) — Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 20 insertion
Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories
Required: HER2 (ERBB2) exon 20 insertion
Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories
Excluded: EGFR p.H773_V774insH
tumor that is known to harbor EGFR ex20ins p.H773_V774insH variant
Excluded: EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations
any EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced or metastatic
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- City of Hope · Huntington Beach, California
- City of Hope · Irvine, California
- Levine Cancer Institute - Charlotte · Charlotte, North Carolina
- Thomas Jefferson University Research Facility · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06043817 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received platinum-based chemotherapy.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 exon 20 insertion is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR p.H773_V774insH is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations 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.
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