Back to Trials
NCT06010329PHASE2Recruiting

A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Teligene US

Start Date

12/27/2023

Completion Date

12/1/2028

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).

Detailed Description

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sutetinib Maleate Capsule

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Non-small Cell Lung Cancer

Locations

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