JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2. The purpose of this study is to studying neoadjuvant JS001, or JS001 in combination with pemetrexed and carboplatin to see how well it works in treating patients with resectable NSCLC.
Surgery in combination with preoperative or postoperative chemotherapy is the recommended therapeutic approach for patients with resectable non-small cell lung cancer (NSCLC). However, the prognosis of early-stage NSCLC remains to be improved, with 5-year survival rates ranging from 50% for stage IA to 20% for stage IIIA. Antibodies that block the PD-1 protein have provided a major treatment advance in patients with cancer. JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which has shown its efficacy in the treatment of a variety of malignancies. This study is to studying neoadjuvant JS001, or JS001 in combination with chemotherapy to see how well it works in treating patients with resectable NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
Subjects receive pemetrexed of 500 mg/m\^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
Subjects receive carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
3-year Disease Free Survival
Disease-free survival was assessed from registration to disease recurrence or death as a result of any cause.
Time frame: 3 years after the last patient is registered
Number of participants with treatment-related adverse events (AEs)
Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Time frame: 2 years after the last patient is registered
Number of participants with perioperative complications
Perioperative complications will be recorded
Time frame: 2 years
3-year Overall survival
Overall survival was assessed from registration to death as a result of any cause.
Time frame: 3 years after the last patient is registered
Pathologic Response
To assess pathologic response to neoadjuvant JS001, or JS001 in combination with chemotherapy in resected tumor and lymph nodes. Major pathologic response was defined as \<10% residual viable tumor cells in the resection specimen.
Time frame: 3 months
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Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.