This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
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 non-resistant uncommon EGFR mutations
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Study drug to be taken orally with or without food (with food preferred) for up to13 cycles
Assessment of Objective response rate (ORR)
Objective response rate (ORR) assessed by IRC
Time frame: 2 Years
Assessment of Duration of response (DoR)
Time frame: 2 Years
Assessment of Disease control rate (DCR)
Time frame: 2 Years
Assessment of Progression free survival (PFS)
Time frame: 2 Years
Assessment of Time to progressive disease
Time frame: 2 Years
Assessment of Time to response
Time frame: 2 Years
Assessment of Time to treatment failure (TTF)
Time frame: 2 Years
Assessment of Overall survival (OS)
Time frame: 2 Years
Assessment of 1-year progression-free survival
Time frame: 1 Year
Assessment of 1-year survival
Time frame: 1 Years
Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs(SAEs)
Time frame: 2 Years
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OPN Healthcare, Inc.
Glendale, California, United States
RECRUITINGUniversity Cancer & Blood Center
Athens, Georgia, United States
RECRUITINGBaptist Health
Louisville, Kentucky, United States
RECRUITINGUniversity of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGFirstHealth Cancer Center
Pinehurst, North Carolina, United States
RECRUITINGThe University of Texas- MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGThe First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
ACTIVE_NOT_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
ACTIVE_NOT_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
ACTIVE_NOT_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
ACTIVE_NOT_RECRUITING...and 16 more locations
Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC)
Time frame: 2 Years