A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: Sutetinib Maleate Capsule
- Registration Number
- NCT06010329
- Lead Sponsor
- Teligene US
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- 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
Other inclusion criteria apply for participating in the study.
- 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
Other exclusion criteria apply for participating in the Study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm, Open label Sutetinib Maleate Capsule Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Pre-dose up to approximately 32 months post-dose
- Secondary Outcome Measures
Name Time Method 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 Time to Treatment Failure (TTF) Pre-dose up to approximately 32 months post-dose Overall Survival (OS) Pre-dose up to approximately 32 months post-dose 1-year Progression Free Survival Pre-dose up to 1 year post-dose Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.
1-year Survival Pre-dose up to 1 year post-dose Ratio of surviving participants 1 year after the first dose of IP.
Area Under The Curve (AUC) of Sutetinib Maleate Capsule Pre-dose up to 24 hours post-dose Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule Pre-dose up to 24 hours post-dose Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule Pre-dose up to 24 hours post-dose Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule Pre-dose up to 24 hours post-dose Sutetinib Maleate Capsule half-life (T1/2) Pre-dose up to 24 hours post-dose Apparent Clearance (CL/f) of Sutetinib Maleate Capsule Pre-dose up to 24 hours post-dose Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule Pre-dose up to 24 hours post-dose Number of Participants Experiencing Adverse Events (AE) Pre-dose up to approximately 32 months post-dose Number of Participants Experiencing Adverse Drug Reactions (ADR) Pre-dose up to approximately 32 months post-dose Number of Participants Experiencing Serious Adverse Events (SAE) Pre-dose up to approximately 32 months post-dose Number of Participants Experiencing Srious Adverse Reactions (SAR) Pre-dose up to approximately 32 months post-dose
Trial Locations
- Locations (9)
Oncology Physicians Network Healthcare
🇺🇸Glendale, California, United States
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University Cancer & Blood Center (UCBC) - Athens
🇺🇸Athens, Georgia, United States
Mission Cancer + Blood - Mission Cancer Foundation
🇺🇸Des Moines, Iowa, United States
Norton Cancer Institute - Downtown
🇺🇸Louisville, Kentucky, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Perlmutter Cancer Center - 34th Street
🇺🇸New York, New York, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States