The study is being conducted to evaluate the efficacy, safety and tolerability of famitinib combined with HS-10296 in subjects with advanced EGFR-mutant NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
Tongji University, Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate (ORR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Depth of Response (DepOR)
Percentage of total target lesion diameter reduced from baseline when at best overall response
Time frame: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Duration of Response (DOR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: From the first partial response or complete response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Disease Control Rate (DCR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Clinical Benefit Ratio (CBR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: From the start of treatment to 6 months
12-month-PFS
12-month-progression free survival rate
Time frame: From the start of treatment to 12 months
Progression-Free-Survival (PFS)
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Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame: up to 2 years
Number of Participants with Clinically significant toxicity
Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time frame: First cycle (21 days)
Rate of Adverse Events and Serious Adverse Events
Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time frame: From the first drug administration to within 30 days after the last dose