OncoMatch/Clinical Trials/NCT06010329
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
Official title: A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)
Is NCT06010329 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Sutetinib Maleate Capsule for non-small cell lung cancer.
Treatment: Sutetinib Maleate Capsule — The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR uncommon mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Exception: Cohort 1: ever used EGFR TKI; Cohort 2: any second generation EGFR TKI
Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2)
Cannot have received: systemic anti-tumor therapy
Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion >30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives.
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
- Oncology Physicians Network Healthcare · Glendale, California
- University of California San Diego Moores Cancer Center · La Jolla, California
- Moffitt Cancer Center · Tampa, Florida
- University Cancer & Blood Center (UCBC) - Athens · Athens, Georgia
- Mission Cancer + Blood - Mission Cancer Foundation · Des Moines, Iowa
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06010329 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR tyrosine kinase inhibitor, systemic anti-tumor therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR uncommon mutation 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