Lung cancer is the malignant tumor with the highest incidence and mortality in China. Non-small cell lung cancer (NSCLC) ,which includes non-squamous cell carcinoma (including adenocarcinoma, large cell carcinoma, and other cell types) and squamous cell carcinoma, accounts for about 80% of lung cancer. Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-gene negative advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option for patients who are effective after 4 to 6 cycles of standard treatment. There is currently no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and safety of maintenance therapy with the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by the first-line standard regimen in advanced NSCLC patients who are effective after standard treatment. With a view to exploring treatment methods that are effective for the maintenance treatment of driver-gene negative advanced NSCLC and have little toxic and side effects,thereby improving the survival prognosis of these patients.
Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-negative advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option for patients who are effective after 4 to 6 cycles of standard treatment. There is currently no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and safety of the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by maintenance therapy in advanced NSCLC that was effective in the first-line standard regimen.Thereby improving the survival prognosis of advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Qualified subjects will be treated with "toripalimab 240mg q21d" as a treatment cycle.
Fujian cancer hospital
Fuzhou, Fujian, China
Progression-free survival (PFS)
PFS by investigator-reported measurements according to CT image. PFS was calculated from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.PD was defined as Overall Response by RECIST criteria v1.1 according to CT image.
Time frame: up to 12 months
Overall survival time
OS was calculated from the date of randomization to death from any cause.
Time frame: Up to 36 months
Objective response rate
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Disease control rate
CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Adverse events rate
Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Time frame: up to 12 months
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