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)
1 other identifier
interventional
66
1 country
9
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2023
Typical duration for phase_2 nonsmall-cell-lung-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
August 24, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 24, 2026
April 1, 2026
3.9 years
August 18, 2023
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Pre-dose up to approximately 32 months post-dose
Secondary Outcomes (20)
Duration of Response (DoR)
Pre-dose up to approximately 32 months post-dose
Disease Control Rate (DCR)
Pre-dose up to approximately 32 months post-dose
Progression Free Survival (PFS)
Pre-dose up to approximately 32 months post-dose
Time to Tumor Progression (TTP)
Pre-dose up to approximately 32 months post-dose
Time to Response (TTR)
Pre-dose up to approximately 32 months post-dose
- +15 more secondary outcomes
Study Arms (1)
Single arm, Open label
EXPERIMENTALParticipants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 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.
- 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
- Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment
- 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
- 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
- Active central nervous system metastases
- Any active infection which has not been controlled at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teligene USlead
Study Sites (9)
Oncology Physicians Network Healthcare
Glendale, California, 91203, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, 30607, United States
Mission Cancer + Blood - Mission Cancer Foundation
Des Moines, Iowa, 50309, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Perlmutter Cancer Center - 34th Street
New York, New York, 10016, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2023
First Posted
August 24, 2023
Study Start
December 27, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share