Clinical Trials in the USA / NCT06010329
Recruiting
Phase 2
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
NCT06010329 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Non-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
Sutetinib Maleate Capsule: Oral administration
Study 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
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.
Primary outcome measure(s)
- Objective Response Rate (ORR) — Pre-dose up to approximately 32 months post-dose
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Oncology Physicians Network Healthcare | Glendale | California | Withdrawn |
| University of California San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| University Cancer & Blood Center (UCBC) - Athens | Athens | Georgia | Recruiting |
| Mission Cancer + Blood - Mission Cancer Foundation | Des Moines | Iowa | Recruiting |
| Norton Cancer Institute - Downtown | Louisville | Kentucky | Withdrawn |
| Northwell Health | New Hyde Park | New York | Active Not Recruiting |
| Perlmutter Cancer Center - 34th Street | New York | New York | Terminated |
| University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | Recruiting |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Chest Hospital | Beijing | Beijing Municipality | Recruiting |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | Guangdong | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | Recruiting |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | Recruiting |
| Jinan Central Hospital | Jinan | Shandong | Recruiting |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | Recruiting |
| West China Hospital, Sichuan University | Chengdu | Sichuan | Recruiting |
| Qujing Central Hospital of Yunnan Province | Qujing | Yunnan | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06010329 on ClinicalTrials.gov ↗ ← All trials in the USA