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 (May 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.

Phase 1/2RecruitingPierre Fabre MedicamentNCT06043817Data as of May 2026

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 qualify

Extracted eligibility criteria

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

Max 2 prior lines

Min 1 prior line

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 →

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 qualify