This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
(IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W)until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
(IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W) until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
The First Hospital of Jilin University
Changchun, Jilin, China
Objective Response Rate(ORR)
Investigator evaluated ORR per RECIST V1.1
Time frame: Up to 2 years
Treatment Emergent Adverse Event (TEAE)
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;
Time frame: Up to 2 years
Severe Adverse Event (SAE)
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;
Time frame: Up to 2 years
DOR
Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;
Time frame: Up to 2 years
Progression Free Survival (PFS)
Defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;
Time frame: Up to 2 years
Overall Survival (OS)
Defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced NSCLC
Time frame: Up to 2 years
Disease Control Rate (DCR)
Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
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Time frame: Up to 2 years
Time to Response (TTR)
Defined as the time from randomization to the first documented and confirmed objective response (CR or PR)
Time frame: Up to 2 years
HRQoL
According to EORTC QLQ-C30
Time frame: Up to 2 years