Sutetinib Maleate Capsule for Advanced Non-Small Cell Lung Cancer

This study is testing Sutetinib Maleate Capsule, a new oral medication, for people with locally advanced or metastatic non-small cell lung cancer (NSCLC). This drug works by targeting specific changes in the EGFR gene, which can cause cancer to grow. You may be able to join if you have NSCLC with certain uncommon EGFR mutations (L861Q, G719X, and/or S768I) and have had one or fewer prior chemotherapy treatments. Researchers want to see how many people respond to Sutetinib Maleate Capsule over two years. The study aims to enroll 99 participants, but its current status is unclear.

Study design
This is a Phase 2b, open-label study, meaning both you and your doctors will know you are receiving Sutetinib Maleate Capsule. It plans to include about 99 participants.
What's involved
You would take Sutetinib Maleate Capsule by mouth, with or without food (food is preferred), for up to 13 cycles.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess your response to the treatment for up to two years.

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

NCT05168566

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Teligene US
~99 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Sutetinib Maleate Capsule

At a glance

Recruiting sites
4 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Objective response rate (ORR)
Measured over 2 Years
Non-small Cell Lung Cancer
26 sites across 21 states
Beijing Municipality4
Henan2
Shanghai Municipality2
California1
Georgia1
Kentucky1
Maryland1
North Carolina1

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  • Assessment of Objective response rate (ORR)2 Years

    Objective response rate (ORR) assessed by IRC