Tests toripalimab with or without tifcemalimab in limited-stage small cell lung cancer
Tests two drugs after chemoradiotherapy in adults with limited-stage small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
Key facts
- Where
- 's-Hertogenbosch, Arnhem, Rotterdam, and Zwolle, NetherlandsSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with limited-stage small cell lung cancer whose disease has not grown after chemotherapy and radiotherapy given together. It tests toripalimab alone or with tifcemalimab.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Limited-stage small cell lung cancer. Stage I or II must be inoperable, or the person must refuse surgery. After treatment, the cancer must be gone, smaller or stable, not growing.
- Earlier treatment
- Must have had chemotherapy (carboplatin or cisplatin with etoposide, 4 cycles) and radiotherapy given together. The trial drugs must start within 42 days of the last chemotherapy dose.
Main reasons for not taking part
- Mixed small cell and non-small cell lung cancer
- Chemotherapy and radiotherapy given one after the other
- Active autoimmune disease or a history of it
- Weak immune system, including HIV, or past organ or bone marrow transplant
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in Netherlands
- Jeroen Bosch Ziekenhuis's-Hertogenbosch, NetherlandsContact: van Veggel B.A.M.H. (Bianca)Not yet recruiting
- Rijnstate ZiekenhuisArnhem, NetherlandsContact: Claessens NielsNot yet recruiting
- Erasmus Medisch CentrumRotterdam, NetherlandsContact: Dumoulin DaphneNot yet recruiting
- Isala Klinieken ZwolleZwolle, NetherlandsContact: Plomp PeterNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Junshi Bioscience Co., Ltd.
- Trial code
- NCT06095583
- Record updated
- 27 July 2026
- Original description
The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy
The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy.
Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.
Inclusion: Patients must meet all of the following inclusion criteria to be enrolled:; Male or female with age ≥ 18 years old at the time of informed consent; Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery; Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy; Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 ; Adequate organ function; Female patients of childbearing potential and male patients whose partners are women of childbearing age; Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.
Exclusion: Received sequential chemoradiotherapy for LS-SCLC; Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion/exclusion criteria, whichever is more severe; History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids); Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (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; Mixed SCLC and non-small cell lung cancer (NSCLC); Patients with active autoimmune disease, history of autoimmune disease; History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; The presence of active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method); Patients will be excluded from the study if they meet any of the following criteria; Women who are pregnant or breastfeeding.