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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Oral administration
Oncology Physicians Network Healthcare
Glendale, California, United States
WITHDRAWNUniversity of California San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGObjective Response Rate (ORR)
Time frame: Pre-dose up to approximately 32 months post-dose
Duration of Response (DoR)
Time frame: Pre-dose up to approximately 32 months post-dose
Disease Control Rate (DCR)
Time frame: Pre-dose up to approximately 32 months post-dose
Progression Free Survival (PFS)
Time frame: Pre-dose up to approximately 32 months post-dose
Time to Tumor Progression (TTP)
Time frame: Pre-dose up to approximately 32 months post-dose
Time to Response (TTR)
Time frame: Pre-dose up to approximately 32 months post-dose
Time to Treatment Failure (TTF)
Time frame: Pre-dose up to approximately 32 months post-dose
Overall Survival (OS)
Time frame: Pre-dose up to approximately 32 months post-dose
1-year Progression Free Survival
Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.
Time frame: Pre-dose up to 1 year post-dose
1-year Survival
Ratio of surviving participants 1 year after the first dose of IP.
Time frame: Pre-dose up to 1 year post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Moffitt Cancer Center
Tampa, Florida, United States
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, United States
RECRUITINGMission Cancer + Blood - Mission Cancer Foundation
Des Moines, Iowa, United States
RECRUITINGNorton Cancer Institute - Downtown
Louisville, Kentucky, United States
WITHDRAWNNorthwell Health
New Hyde Park, New York, United States
ACTIVE_NOT_RECRUITINGPerlmutter Cancer Center - 34th Street
New York, New York, United States
RECRUITINGUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGArea Under The Curve (AUC) of Sutetinib Maleate Capsule
Time frame: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule
Time frame: Pre-dose up to 24 hours post-dose
Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule
Time frame: Pre-dose up to 24 hours post-dose
Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule
Time frame: Pre-dose up to 24 hours post-dose
Sutetinib Maleate Capsule half-life (T1/2)
Time frame: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of Sutetinib Maleate Capsule
Time frame: Pre-dose up to 24 hours post-dose
Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule
Time frame: Pre-dose up to 24 hours post-dose
Number of Participants Experiencing Adverse Events (AE)
Time frame: Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time frame: Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Srious Adverse Reactions (SAR)
Time frame: Pre-dose up to approximately 32 months post-dose