Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage … (NCT06648200) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer
China100 participantsStarted 2024-11-01
Plain-language summary
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.
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
. The patient shall sign the Informed Consent Form;
. Aged 18 ≥ years;
. Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
. Life expectancy is at least 12 weeks;
. At least 1 measurable lesion according to RECIST 1.1;
. Patients with good function of other main organs (liver, kidney, blood system, etc.);
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
Progression-free survival (PFS)
Timeframe: up to 60 months
Trial details
NCT IDNCT06648200
SponsorShanghai Pulmonary Hospital, Shanghai, China
. Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;
Exclusion criteria
. Patients with a malignancy other than SCLC within five years prior to the start of this trial;
. Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
. Participants who are allergic to the test drug or any auxiliary materials;
. Participants with active hepatitis B, hepatitis C or HIV;
. Participants with Interstitial lung disease currently;