This study aims to explore time-of-day of administration of immunochemotherapy on the efficacy for treatment naive advanced non-small cell lung cancer.
All the advanced NSCLC patients who were treated with chemotherapy plus pembrolizumab or sitilimab will be randomized to two groups. One for morning group, the patients in this group were treated with chemotherapy plus pembrolizumab or sintilimab before 15:00. One for afternoon group, the patients in this group were treated with chemotherapy plus pembrolizumab or sintilimab after 15:00.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
One for morning group, the patients in this group were treated with immunochemotherapy before 15:00. One for afternoon group, the patients in this group were treated with immunochemotherapy after 15:00.
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGProgression-free survival (PFS)
To assess progression-free survival of patients treated by immunochemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause.
Time frame: Time from first subject dose to study completion, or up to 36 month.
Objective Response Rate (ORR)
To assess immunochemotherapy overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Time frame: Time from first dose to last dose, or up to 24 month.
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause.
Time frame: Time from first subject dose to study completion, or up to 24 month.
Duration of Response (DoR)
To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death
Time frame: Time from first subject dose to study completion, or up to 24 month.
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