This study is a randomized, double-blind, placebo-controlled, multi-center clinical study. Target population is patients with stage IV non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of Camrelizumab + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT with placebo + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
Detailed Description: In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Paticipant was confirmed without EGFR activating mutation or ALK fusion and received no prior systemic therapy. Patients would receive Camrelizumab/placebo in combination with chemotherapy for 4-6 cycles,non-squamous subject followed by Camrelizumab/placebo + pemetrexed as maintenance treatment until progression or unacceptable toxicity, squamous subject followed by Camrelizumab/placebo as maintenance treatment until progression or unacceptable toxicity, Camrelizumab/placebo for a maximum of 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody
IV infusion Simulator of Camrelizumab
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Intracranial Progression-Free Survival(iPFS)
Intracranial Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression in brain metastasis disease or death from any cause or switch therapy
Time frame: up to 24 month
Intracranial Objective Response Rate (iORR)
iORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response(PR: ≥30% decrease in the sum of diameters of target lesions) in brain lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: up to 24 month
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a CR or a PR.
Time frame: up to 24 month
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time frame: up to 24 month
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: up to 24 month
Duration of Response (DOR)
DOR was defined as the time from first documented evidence of a CR or PR until PD or death
Time frame: up to 24 month
Quality of Life (QoL)
Evaluate according to the quality of life score V3.0,higher scores mean a better outcome.
Time frame: up to 24 month
Adverse events (AEs)/ Serious adverse event (SAE)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Time frame: up to 24 month
Simple Mental State Scale of Intelligence (MMSE)
Assessment of cognitive function based on the MMSE ,the values from 0 to 30, higher scores mean a better outcome.
Time frame: up to 24 month
Revised Hopkins Vocabulary Learning Test Scale (HVLT-R)
Assessment of cognitive function based on the HVLT-R,higher scores mean a better outcome.
Time frame: up to 24 month
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