JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）

Phase 3

Recruiting

• Conditions: Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
• Interventions: Drug: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy; Drug: 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

A randomized, open-label,multicenter, phase III clinical study was designed to enroll 356 participants with recurrent or metastatic Non-Squamous Non small cell lung cancer without EGFR sensitive mutations or ALK fusion. They will be randomly assigned in a 1:1 ratio to one of two treatment groups: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.

Study Timeline

• Study First Submitted: 2024-05-19
• Status Verified: 2024-07
• Study Start: 2024-07-11
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-17
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

Exclusion Criteria

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

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changshang, Hunan, China