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
- Tbilisi, GeorgiaSee the 7 sites
- Phase
- Phase 3
Where in Georgia
- "TIM - Tbilisi Institute of Medicine" LTDTbilisi, GeorgiaNot yet recruiting
- ICO-Institute of Clinical Oncology - HospitalTbilisi, GeorgiaTaking people
- ISR-GEO Med Res Clin HealthycoreTbilisi, GeorgiaTaking people
- LTD "Israel-Georgian Medical Research Clinic Healthycore"Tbilisi, GeorgiaTaking people
- LTD "New Hospitals"Tbilisi, GeorgiaTaking people
- Multprofil Clinic Consilium MedullaTbilisi, GeorgiaTaking people
- Tbilisi State Medical University and Ingorokva High Medical Technology University ClinicTbilisi, GeorgiaTaking people
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?
Trial 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.