RecruitingPhase 2NCT06010329

A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

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).

Checked against the public recordLast updated Apr 24, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 2
U.S. locations9
SponsorTeligene US
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Teligene US
Interventions being studied
Drug: Sutetinib Maleate Capsule
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Age 18 years old and above, male or female 2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC 3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy) 4. At least one measurable lesion 5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 6. A minimum life expectancy of \> 3 months 7. Adequate bone marrow reserve, hepatic, renal, and coagulation function Other inclusion criteria apply for participating in the study. Exclusion Criteria: 1. 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) 2. 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. 3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment 5. Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia 6. Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption 7. Active central nervous system metastases 8. Any active infection which has not been controlled at screening Other exclusion criteria apply for participating in the Study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Oncology Physicians Network HealthcareGlendale, California
  • University of California San Diego Moores Cancer CenterLa Jolla, California
  • Moffitt Cancer CenterTampa, Florida
  • University Cancer & Blood Center (UCBC) - AthensAthens, Georgia
  • Mission Cancer + Blood - Mission Cancer FoundationDes Moines, Iowa
  • Norton Cancer Institute - DowntownLouisville, Kentucky
  • Northwell HealthNew Hyde Park, New York
  • Perlmutter Cancer Center - 34th StreetNew York, New York
  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 24, 2026. Always confirm current availability with the study team.

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