OncoMatch/Clinical Trials/NCT05168566
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Official title: A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Is NCT05168566 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Sutetinib Maleate Capsule for non-small cell lung cancer.
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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR g719x
Required: EGFR l861q
Required: EGFR s768i
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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
- Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., District of Columbia
- University Cancer & Blood Center · Athens, Georgia
- Baptist Health · Louisville, Kentucky
- University of Maryland Medical Center · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05168566 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior egfr tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR g719x is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l861q is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR s768i is a required biomarker for enrollment.
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