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

NCT06505837 | Active Not Recruiting Phase 3

• 1 other identifier: JS001sc-002-III-NSCLC
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Observed serum Ctrough at Cycle 1

  Measured valley concentration at the end of cycle 1 (Ctrough)

  the end of Cycle 1 (Each cycle is 21 days)

• Model-predicted area under the concentration-time curve(AUC) from 0 to 21 days at Cycle 1

  The area under the drug time curve of cycle 1 simulated by a population pharmacokinetic model

  the end of Cycle 1 (Each cycle is 21 days)

Secondary Outcomes (6)

• Objective response rate (ORR)

  up to 2years

• Progression-free survival (PFS)

  up to 2years

• 6-month progression-free survival(PFS) rate

  up to 6-month

• Disease control rate (DCR)

  up to 2years

• Duration of response (DoR)

  up to 2years

Study Arms (2)

Arm1:JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy

EXPERIMENTAL

Drug: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy

Arm 2:JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy

ACTIVE COMPARATOR

Drug: JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy

Interventions

JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy DRUG

The combination therapy of JS001sc and pemetrexed/platinum lasted for 4 cycles, after which subjects who did not progress continued to receive JS001sc and pemetrexed maintenance therapy, and the cumulative treatment of JS001sc did not exceed 35 cycles (Each cycle is 21 days).

Arm1:JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy

JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy DRUG

The combination therapy of JS001 and pemetrexed/platinum lasted for 4 cycles, after which subjects who did not progress continued to receive JS001 and pemetrexed maintenance therapy, and the cumulative treatment of JS001 did not exceed 35 cycles (Each cycle is 21 days).

Arm 2:JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of signing informed consent, both male and female.
• Histologically or cytologically confirmed relapsed or metastatic non-squamous NSCLC.
• A test report confirming the absence of EGFR sensitive mutations and ALK fusions (local laboratory reports are acceptable, but the tests must be well-validated and either pass external quality assessment or be qualified for molecular pathology diagnosis/gene testing or approved by NMPA).
• No prior systemic anti-tumor therapy for advanced or metastatic non-squamous NSCLC. Subjects who have received adjuvant therapy or neoadjuvant therapy (chemotherapy, radiotherapy, or other treatments) for recurrent non-squamous NSCLC can be enrolled if the interval between the last treatment and recurrence is more than 6 months.
• Subject has at least 1 measurable lesion according to RECIST v1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival ≥ 12 weeks.
• The function of vital organs meets the following requirements (Note: no blood components and hematopoietic growth factors are allowed to be used within 14 days before screening);
• Absolute neutrophil count (ANC) ≥1.5×109/L；
• Platelet ≥ 100×109/L;
• Hemoglobin ≥9 g/dL;
• Bilirubin ≤1.5× upper limit of normal (ULN);
• Alanine aminotransferase (ALT) ≤ 2.5× ULN, aspartate aminotransferase (AST) ≤ 2.5× ULN;
• Creatinine clearance (CrCL) ≥ 60 mL/min (cisplatin) or CrCL ≥50 mL/min (carboplatin) (Cockcroft-Gault formula);
• Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, International normalized ratio (INR) ≤ 1.5 (for prophylactic anticoagulation at stable doses, drug-specific monitoring requirements are acceptable beyond this range)；

You may not qualify if:

• Concomitant study disease states of：
• Histological or cytological pathology of the tumor confirmed with small cell lung cancer component or sarcomatoid lesion, or squamous cell carcinoma component \>10%;
• Patients with known meningeal metastasis; patients with symptomatic brain metastases; patients with asymptomatic brain metastases, who have been evaluated by the investigators as stable can be enrolled, including: 1) Those who have maintained stability after receiving radiotherapy for brain metastases, and the stability criteria need to meet all of the following conditions: no symptoms related to brain metastases, at least 7 days before the administration of the study drug, no disease progression was found in the imaging examination after the brain metastasis treatment compared to the imaging examination before the treatment (at least a 4-week interval); 2) Those without local treatment for asymptomatic brain metastases, and need to meet all of the following conditions: no use of corticosteroids or other drugs to control symptoms related to brain metastases, no long diameter of any brain metastasis lesion ≥ 1 cm, no metastasis in the midbrain, pons, medulla oblongata, cerebellum or spinal cord, and no history of intracranial hemorrhage in the past;
• Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage (once a month or more frequently); subjects with stable symptoms after drainage for at least two weeks can be enrolled;
• Spinal cord compression that has not been treated surgically and/or radiotherapeutically, or those diagnosed with spinal cord compression in the past who have no clinical evidence showing disease stability ≥ 4 weeks before enrollment;
• Known to have other existing standard first-line treatment-driven gene mutations, including but not limited to: ROS1 fusion, BRAF V600 mutation, MET14 exon skipping mutation, RET fusion;2. Have received any of the following treatments；
• Have received any of the following treatments:
• Received local small-area radiotherapy (such as palliative radiotherapy for bone metastases) within 14 days prior to the first study drug administration;
• Prior immune-mediated therapy, including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy (or any other antibodies acting on T cell synergistic stimulation or checkpoint pathways such as IDO, IL-2R, GITR);
• Receipt of any investigational drug within 4 weeks or 5 half-lives prior to the first dose of study drug, whichever is shorter;
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or the subject is in the follow-up period of the interventional clinical study;
• Systemic therapy with corticosteroids (\> 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids are permitted. Receipt of short-term corticosteroids (such as pre-intravenous contrast) within 2 weeks prior to the first dose of study drug is permitted;
• Subjects who have received proprietary Chinese medicines or immunomodulatory drugs with anti-tumor indications (thymus peptide, interferon, interleukin, etc.) within 2 weeks before the first dose of study drug, or who need to continue to receive these drugs during the study;
• Those who have been vaccinated with anti-tumor vaccines or have received live vaccines within 4 weeks before the first dose of study drug;
• Major surgery or severe trauma within 4 weeks prior to the first use of study drug；

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

Hunan Cancer Hospital

Changshang, Hunan, 410013, China

Location

MeSH Terms

Interventions

Injections, Subcutaneous; Pemetrexed; Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Administration, Intravenous; Infusions, Parenteral

Study Officials

• Weihua Wang, doctorate

  Medical director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: July 17, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)