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
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years old and above, male or female
• Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
• Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
• At least one measurable lesion
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
• A minimum life expectancy of \> 3 months
• Adequate bone marrow reserve, hepatic, renal, and coagulation function
⁃ Other inclusion criteria apply for participating in the study.
Locations
United States
California
Oncology Physicians Network Healthcare
WITHDRAWN
Glendale
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
University Cancer & Blood Center (UCBC) - Athens
RECRUITING
Athens
Iowa
Mission Cancer + Blood - Mission Cancer Foundation
RECRUITING
Des Moines
Kentucky
Norton Cancer Institute - Downtown
WITHDRAWN
Louisville
New York
Northwell Health
ACTIVE_NOT_RECRUITING
New Hyde Park
Perlmutter Cancer Center - 34th Street
RECRUITING
New York
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Xiaoyang Xia
Xiaoyang.xia@teligene.com
805-300-9373
Backup
Dawei Zhang
david.zhang@teligene.com
805-300-1019
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2026-04
Participants
Target number of participants: 66
Treatments
Experimental: Single arm, Open label
Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.
Related Therapeutic Areas
Sponsors
Leads: Teligene US