NCT06010329

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Teligene US · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sutetinib Maleate Capsule	Oral administration

Timeline

• Start date: 2023-12-27
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-08-24
• Last updated: 2025-03-21

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study