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
60
Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody
IV infusion Simulator of Camrelizumab
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fujian, Fuzhou, China
Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, China
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
...and 4 more locations
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 months
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 months
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 months
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 months
Intracranial Duration of Response (iDOR)
iDOR was defined as the time from first documented evidence of a CR or PR until PD or death
Time frame: up to 24 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: up to death
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 months
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 months
Mini-Mental State Examination (MMSE)
Assessment of cognitive function using the Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, registration, attention and calculation, recall, and language. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months
Hopkins Verbal Learning Test - Revised (HVLT-R)
Assessment of verbal learning and memory using the Hopkins Verbal Learning Test - Revised (HVLT-R). The HVLT-R consists of three learning trials of a 12-word list, a delayed recall trial, and a delayed recognition trial. Total recall score (trials 1-3) ranges from 0 to 36, delayed recall score from 0 to 12, and recognition discrimination index from -12 to 12. Higher scores indicate better verbal learning and memory function.
Time frame: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months
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