JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）
- Conditions
- Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
- Interventions
- Drug: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapyDrug: JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy
- Registration Number
- NCT06505837
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
This is a multicenter, open-Lable, randomized, phase III clinical study to compare the pharmacokinetic profile, efficacy, and safety of Toripalimab injection (subcutaneous) (JS001sc) and Toripalimab injection (JS001) in combination with standard chemotherapy as first-line treatment for recurrent or metastatic Non-Squamous Non small cell lung cancer
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 395
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm1:JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy - Arm 2:JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy -
- Primary Outcome Measures
Name Time Method Observed serum Ctrough at Cycle 1 the end of Cycle 1 (Each cycle is 21 days) Measured valley concentration at the end of cycle 1 (Ctrough)
Model-predicted area under the concentration-time curve(AUC) from 0 to 21 days at Cycle 1 the end of Cycle 1 (Each cycle is 21 days) The area under the drug time curve of cycle 1 simulated by a population pharmacokinetic model
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) up to 2years Comparison of first-line Disease control rate (DCR) between JS001sc and JS001 in patients with relapsed or metastatic non-squamous NSCLC
Safety: adverse events (AEs) up to 2years The safety of JS001sc and JS001 as first-line treatment in subjects with relapsed or metastatic non-squamous-scale NSCLC was compared by adverse event rate (percentage of participants with treaty-related adverse events assessed by CTCAEv5.0) and abnormal laboratory parameters.
Progression-free survival (PFS) up to 2years Comparison of first-line Progression-free survival (PFS) between JS001sc and JS001 in patients treated with relapsed or metastatic non-squamous NSCLC
Duration of response (DoR) up to 2years Comparison of first-line Duration of response (DoR) between JS001sc and JS001 in patients treated with relapsed or metastatic non-squamous NSCLC
Objective response rate (ORR) up to 2years Comparison of Objective response rate (ORR) between JS001sc and JS001 in first-line patients with relapsed or metastatic non-squamous NSCLC
6-month progression-free survival(PFS) rate up to 6-month The 6-month progression-free survival(PFS) rate in first-line patients treated with relapsed or metastatic non-squamous NSCLC was compared between JS001sc and JS001
Related Research Topics
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Trial Locations
- Locations (1)
Hunan Cancer Hospital
🇨🇳Changshang, Hunan, China
Hunan Cancer Hospital🇨🇳Changshang, Hunan, ChinaLin Wu, doctoratePrincipal Investigator