The aim of this study is to explore safety and therapeutic efficacy of anlotinib combined with erlotinib/chemotherapy/IBI308 as first-line treatment in advanced NSCLC patients. The primary endpoints of the study are safety and objective response rate (ORR);the secondary endpoints are disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Patient harboring EGFR mutation will be enrolled into arm A. Patients without sensitive EGFR mutation will be assigned to either arm B or arm C based on patients' or treating physicians'choice
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSafety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)
Time frame: from initiation of treatment to 90 days after the treatment finished
ORR
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Time frame: at the time of 8 weeks (2 cycles after treatment)
DCR
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Time frame: at the time of 8 weeks (2 cycles after treatment)
PFS
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
OS
OS is calculated from diagnosis to death or last follow-up time.
Time frame: From date of treatment until the date of death from any cause, assessed up to 50 months
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