A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
NCT ID: NCT06010329
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2023-12-27
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Sutetinib Maleate Capsule
Oral administration
Interventions
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Sutetinib Maleate Capsule
Oral administration
Eligibility Criteria
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Inclusion Criteria
2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
4. At least one measurable lesion
5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
6. A minimum life expectancy of \> 3 months
7. Adequate bone marrow reserve, hepatic, renal, and coagulation function
Exclusion Criteria
2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives.
3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment
4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment
5. Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia
6. Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption
7. Active central nervous system metastases
8. Any active infection which has not been controlled at screening
18 Years
ALL
No
Sponsors
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Teligene US
INDUSTRY
Responsible Party
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Locations
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University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, United States
Mission Cancer + Blood - Mission Cancer Foundation
Des Moines, Iowa, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States
Oncology Physicians Network Healthcare
Glendale, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwell Health
New Hyde Park, New York, United States
Perlmutter Cancer Center - 34th Street
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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TL-EGFR-2201
Identifier Type: -
Identifier Source: org_study_id
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