Open-Label, Randomized, Phase III Clinical Study Comparing the Pharmacokinetic Profile, Efficacy, and Safety of JS001sc and JS001 in Combination With Standard Chemotherapy as First-Line Treatment for Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer

Brief Summary

Detailed Description

This study adopted a randomized, open-label, positive control, multicenter, phase III clinical research design. It selected patients with recurrent or metastatic non-squamous NSCLC who did not have sensitive EGFR mutations or ALK fusions. A total of 356 patients (increased to 395 according to the recommendation of the Data Monitoring Committee) were planned to be enrolled. They would be randomly assigned to one of the following two treatment groups at a ratio of 1:1: Group A: JS001sc+ platinum-based chemotherapy JS001sc, 360 mg, was administered subcutaneously (SC) once every 3 weeks (Q3W). Chemotherapy: pemetrexed + carboplatin/cisplatin, Q3W, up to 4 cycles, non-progressive subjects pemetrexed monotherapy maintenance therapy. Group B: JS001+ platinum-based chemotherapy JS001, 240 mg, IV, Q3W. Chemotherapy: pemetrexed + carboplatin/cisplatin, Q3W, up to 4 cycles, non-progressive subjects pemetrexed monotherapy maintenance therapy. Both groups were treated until treatment termination criteria were met. This study was divided into screening, treatment and follow-up periods. Screening period After signing the Informed consent form (ICF), the subjects entered the study screening period. The screening period was up to 28 days, and subjects who met all inclusion criteria and did not meet any exclusion criteria entered the study treatment period. Period of treatment Tests and evaluations should be completed before each dose. Subjects were assigned to receive JS001sc or JS001 combined with pemetrexed plus carboplatin/cisplatin chemotherapy until the criteria for treatment discontinuation were met. Patients with progressive disease (PD) according to RECIST v1.1 criteria at the first evaluation were allowed to continue treatment until the criteria for discontinuation of treatment were met after discussion with the sponsor and with the investigator's judgment that the patient was clinically stable and could potentially continue to benefit. During the study, the efficacy will be evaluated per RECIST v1.1 criteria. Protocol efficacy and safety assessments should be completed according to the Evaluation Schedule (SoA). Follow-up period The safety follow-ups were 30 days (±7 days) and 90 days (±7 days) after the last study dose or before starting a new antitumor therapy, whichever occurred first. Survival follow-up was performed every 30 days (±7 days) from the last dose of medication until death, loss to follow-up, withdrawal of consent, or termination of the study by the sponsor.

Primary Outcomes

Secondary Outcomes

• Disease control rate (DCR)(up to 2years)
• Safety: adverse events (AEs)(up to 2years)
• Progression-free survival (PFS)(up to 2years)
• Duration of response (DoR)(up to 2years)
• Objective response rate (ORR)(up to 2years)
• 6-month progression-free survival(PFS) rate(up to 6-month)