JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamou… (NCT06505837) | Clinical Trial Compass
Active — Not RecruitingPhase 3
JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）
China395 participantsStarted 2024-07-11
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Observed serum Ctrough at Cycle 1
Timeframe: 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
Timeframe: the end of Cycle 1 (Each cycle is 21 days)
. 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);
Exclusion criteria
. 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;