The purpose of this study is to explore the efficacy and safety of Camrelizumab in combination with nb-Paclitaxel in treating patients with recurrent/metastatic non-small-cell lung cancer.
Camrelizumab is a humanized monoclonal antibody against Programmed death 1(PD-1). Albumin-bound paclitaxel is a new nano-paclitaxel drug coated with human albumin. Patients with recurrent/metastatic non-small-cell lung cancer after the failure of platinum-based therapy will received Camrelizumab 200mg((3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks. The efficacy and safety will be observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg (3mg/kg for underweight patients).
nb-Paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 260mg/m2 for 4-6 cycles.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
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: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 12 months
12-month PFS rate
The rate of 12-month PFS
Time frame: From date of enrollment up to 12 months
Progression-free Survival (PFS)
Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause
Time frame: Time Frame: Up to approximately 24 months
Overall survival (OS)
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Time frame: Up to approximately 24 months
Duration of Response (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.
Time frame: Up to approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 24 months
Incidence of Adverse Events (AEs) in the treatment of Camrelizumab in combination with nb-Paclitaxel
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Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Time frame: Up to approximately 24 months