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Recurrent Metastatic Non-Squamous Non Small Cell Lung CancerPhase 3NCT06505837

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

A Phase 3 study testing JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy and JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy in people with Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy and JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
395 participants
Where
1 siteChina
Study dates
11 Jul 2024to 30 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)；
  • Female subjects who are capable of reproduction, as well as male subjects whose partners are of childbearing age (as listed in Appendix 5), are required to use an effective form of contraception during the study treatment period and for at least 6 months after the last treatment (as stated in Appendix 7)；
  • Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up plan；

Who cannot join

  • 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；
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  • 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；
  • Toxicity from previous anti-tumor therapy has not recovered to ≤ CTCAE grade 1 (except for toxicity judged by the investigator to have no safety risk);
  • Known hypersensitivity to any of the study treatments and their excipients;
  • Unable or unwilling to use folic acid or vitamin B12 injection;
  • Active autoimmune disease, history of autoimmune disease (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); except for:
  • Subjects with vitiligo or cured childhood asthma/allergies that do not require any intervention after adulthood;
  • Subjects with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone;
  • Subjects on stable doses of insulin for the treatment of type I diabetes mellitus;
  • Subjects with well-controlled hyperthyroidism after adequate treatment；
  • Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
  • Severe infection (CTCAE> grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, infection comorbidities, etc., active lung inflammation on baseline chest imaging, symptoms and signs of infection within 2 weeks prior to the first dose of the study drug requiring oral or intravenous antibiotic treatment (except for prophylactic antibiotic use);
  • Confirmed or suspected history of interstitial lung disease or idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or other moderate to severe pulmonary diseases that seriously affect lung function (except for ≤ grade 1 radiation pneumonitis);
  • Subjects with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or subjects with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment;
  • Presence of active hepatitis B (hepatitis B virus surface antigen (HBsAg) positive with HBV DNA ≥500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method);
  • Diagnosis of any other malignancy prior to the first dose of study drug within 5 years, with the exception of malignancies with low risk of metastasis (5-year survival rate >90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer;
  • Pregnant or lactating women;
  • Uncontrolled concurrent diseases, including but not limited to: symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) < 50%, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, major epileptic seizures, superior vena cava syndrome, or other conditions that may affect study compliance, significantly increase the risk of adverse events, or impair the ability of subjects to provide written informed consent; such as mental disorders/societal conditions；
  • As judged by the investigator, the subject has other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illnesses) requiring concomitant treatment, serious abnormalities in laboratory test values, and/or family or social factors that may affect the safety of the subject or the collection of experimental data；

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Cancer Hospital

    Changshang, Hunan, 410013

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy, JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapyDrug

    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).

  • JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapyDrug

    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).

Study groups in NCT06505837
Study groupRoleWhat they receive
Arm1:JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapyExperimentalNot described
Receives: Drug: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy
Arm 2:JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapyActive comparatorNot described
Receives: Drug: JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observed serum Ctrough at Cycle 1

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

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

  2. 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

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

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Comparison of Objective response rate (ORR) between JS001sc and JS001 in first-line patients with relapsed or metastatic non-squamous NSCLC

    Measured: up to 2years

  2. Progression-free survival (PFS)

    Comparison of first-line Progression-free survival (PFS) between JS001sc and JS001 in patients treated with relapsed or metastatic non-squamous NSCLC

    Measured: up to 2years

  3. 6-month progression-free survival(PFS) rate

    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

    Measured: up to 6-month

  4. Disease control rate (DCR)

    Comparison of first-line Disease control rate (DCR) between JS001sc and JS001 in patients with relapsed or metastatic non-squamous NSCLC

    Measured: up to 2years

  5. Duration of response (DoR)

    Comparison of first-line Duration of response (DoR) between JS001sc and JS001 in patients treated with relapsed or metastatic non-squamous NSCLC

    Measured: up to 2years

  6. Safety: adverse events (AEs)

    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.

    Measured: up to 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start11 Jul 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel
Masking
None (open label)
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06505837
Sponsor's protocol ID
JS001sc-002-III-NSCLC
Status last verified
Aug 2025
First submitted
19 May 2024
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy and JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy in people with Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed serum Ctrough at Cycle 1 (time frame: the end of Cycle 1 (Each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06505837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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