Evaluating Sutetinib for Advanced Non-Small Cell Lung Cancer
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)
This study is testing a new drug called sutetinib to see if it can help people with advanced lung cancer that has specific gene mutations.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teligene US Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, sutetinib |
| Locations | 9 sites (Glendale, California and 8 other locations) |
| Trial ID | NCT06010329 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of sutetinib maleate capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that have uncommon EGFR mutations. Sutetinib is an investigational drug that works as an irreversible EGFR tyrosine kinase inhibitor, targeting mutated forms of the EGFR gene that contribute to cancer growth. Participants will be monitored for treatment response and safety outcomes, with eligibility criteria focusing on specific tumor characteristics and patient health status.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed locally advanced or metastatic NSCLC harboring uncommon EGFR mutations.
Not a fit: Patients who have previously received EGFR tyrosine kinase inhibitors or certain systemic anti-tumor therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with uncommon EGFR mutations in NSCLC.
How similar studies have performed: Other studies have shown promise with EGFR inhibitors in NSCLC, but this specific approach with sutetinib is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years old and above, male or female 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 Other inclusion criteria apply for participating in the study. Exclusion Criteria: 1. 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) 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 Other exclusion criteria apply for participating in the Study.
Where this trial is running
Glendale, California and 8 other locations
- Oncology Physicians Network Healthcare — Glendale, California, United States (Withdrawn)
- University of California San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- University Cancer & Blood Center (UCBC) - Athens — Athens, Georgia, United States (Recruiting)
- Mission Cancer + Blood - Mission Cancer Foundation — Des Moines, Iowa, United States (Recruiting)
- Norton Cancer Institute - Downtown — Louisville, Kentucky, United States (Withdrawn)
- Northwell Health — New Hyde Park, New York, United States (Active_not_recruiting)
- Perlmutter Cancer Center - 34th Street — New York, New York, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Xiaoyang Xia
- Email: Xiaoyang.xia@teligene.com
- Phone: 805-300-9373
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.