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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
Phase
Phase 2
Started
2023-12-27
Last updated
2026-11-02

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Sutetinib Maleate Capsule →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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