The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy
This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A human anti-PD-1 monoclonal antibody
A tyrosine kinase inhibitor selectively targeting VEGFR-2
China
Beijing, Beijing Municipality, China
RECRUITINGProgression-free Survival (PFS)
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time frame: up to 1 year
Objective response rate (ORR)
ORR 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: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.
Time frame: up to 1 year
Duration of Response
Duration of Response, determined using RECIST v1.1 criteria
Time frame: up to 1 year
Disease Control Rate (DCR)
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: up to 1 year
Overall Survival (OS)
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
Time frame: up to 2 years
Adverse Events (AEs) and Serious Adverse Events(SAEs)
The number of participants experiencing an AE and SAE will be assessed.Adverse
Time frame: up to 1 year
QLQ-LC13
Quality of Life questionnaire lung cancer module 13
Time frame: up to 1 years
EORTCQLQ-C30
European Organization for Reasearch and Treatment of Cancer C30
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Time frame: up to 1 years