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

NCT05168566 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-04-28

No results posted yet for this study

Summary

This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Conditions

Interventions

DRUG

Sutetinib Maleate Capsule

Study drug to be taken orally with or without food (with food preferred) for up to13 cycles

Sponsors & Collaborators

  • Teligene US

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05168566 on ClinicalTrials.gov