Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
Led by Teligene US · Updated on 2026-04-24
66
Participants Needed
9
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 EGFR mutation (tumor tissue biopsy)
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Minimum life expectancy greater than 3 months
- Adequate bone marrow reserve, liver, kidney, and blood clotting function
- Other inclusion criteria apply for participating in the study
You will not qualify if you...
- Prior use of EGFR tyrosine kinase inhibitors for anti-tumor therapy (Cohort 1), or second generation EGFR TKIs (Cohort 2)
- Use of systemic anti-tumor therapies such as chemotherapy or radiation within 3 weeks before enrollment; immunotherapy within 4 weeks; palliative radiotherapy for non-target lesions or traditional Chinese medicines for tumor within 2 weeks before enrollment; Cohort 2: any EGFR TKIs within 5 half-lives
- Use of drugs or foods containing strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives before enrollment
- Surgical operation (excluding aspiration biopsy) of main organs or significant injury within 4 weeks prior to enrollment
- Unresolved toxicities from prior therapy greater than Grade 1 except alopecia at screening
- Inability to swallow study medication or serious chronic gastrointestinal disorders affecting absorption
- Active central nervous system metastases
- Any uncontrolled active infection at screening
- Other exclusion criteria apply for participating in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Oncology Physicians Network Healthcare
Glendale, California, United States, 91203
Withdrawn
2
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, United States, 30607
Actively Recruiting
5
Mission Cancer + Blood - Mission Cancer Foundation
Des Moines, Iowa, United States, 50309
Actively Recruiting
6
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States, 40202
Withdrawn
7
Northwell Health
New Hyde Park, New York, United States, 11042
Active, Not Recruiting
8
Perlmutter Cancer Center - 34th Street
New York, New York, United States, 10016
Actively Recruiting
9
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
X
Xiaoyang Xia
CONTACT
D
Dawei Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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