Sutetinib Maleate Capsule for Advanced NSCLC with Uncommon EGFR Mutations

This study is testing a drug called Sutetinib Maleate Capsule for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific uncommon changes (mutations) in the EGFR gene. Sutetinib Maleate Capsule is an investigational drug that works by blocking certain proteins (tyrosine kinase inhibitor) involved in cancer growth. Researchers want to see how well Sutetinib Maleate Capsule shrinks tumors (Objective Response Rate) over about 32 months. To join, you must be at least 18 years old, have NSCLC confirmed by a doctor, and your tumor must have an uncommon EGFR mutation. You also need to have at least one measurable tumor and a good general health score.

Study design
This is an interventional study with a planned enrollment of 66 participants. It is evaluating Sutetinib Maleate Capsule for non-small cell lung cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for objective response rate from pre-dose up to approximately 32 months post-dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06010329

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Teligene US
~66 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Sutetinib Maleate Capsule

At a glance

Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Pre-dose up to approximately 32 months post-dose
Non-small Cell Lung Cancer
9 sites across 7 states
California2
New York2
Florida1
Georgia1
Iowa1
Kentucky1
Texas1

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  • Objective Response Rate (ORR)Pre-dose up to approximately 32 months post-dose