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OncoMatch/Clinical Trials/NCT05168566

Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

Is NCT05168566 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sutetinib Maleate Capsule for non-small cell lung cancer.

Phase 2RecruitingTeligene USNCT05168566Data as of May 2026

Treatment: Sutetinib Maleate Capsule — This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR L861Q

Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes.

Required: EGFR G719X

Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes.

Required: EGFR S768I

Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line

Cannot have received: egfr tyrosine kinase inhibitor

Lab requirements

Blood counts

adequate bone marrow reserve

Kidney function

adequate renal function

Liver function

adequate hepatic function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • OPN Healthcare, Inc. · Glendale, California
  • University Cancer & Blood Center · Athens, Georgia
  • Baptist Health · Louisville, Kentucky
  • University of Maryland Medical Center · Baltimore, Maryland
  • FirstHealth Cancer Center · Pinehurst, North Carolina

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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