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)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Limited-stage Small Cell Lung Cancer (LS-SCLC)

In brief

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.

Key facts

Study ID

NCT06095583

Run by

Shanghai Junshi Bioscience Co., Ltd.

People needed

756

Starts

2023-11-15

Expected to finish

2029-07-31

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients will be excluded from the study if they meet any of the following criteria.
• Mixed SCLC and non-small cell lung cancer (NSCLC).
• 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.
• 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.
• History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
• 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).
• 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.
• Women who are pregnant or breastfeeding.

Where it is running

• ISR-GEO Med Res Clin Healthycore — Tbilisi, K'alak'i T'bilisi, Georgia (enrolling)
• Multprofil Clinic Consilium Medulla — Tbilisi, K'alak'i T'bilisi, Georgia (enrolling)
• Hubei Cancer Hospital (Hubei Cancer Research Institute) — Wuhan, China (enrolling)
• General Hospital of Ningxia Medical University — Yinchuan, China (enrolling)
• Ltd New Hospitals — Tbilisi, K'alak'i T'bilisi, Georgia (enrolling)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (enrolling)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (enrolling)
• Hunan Cancer Hospital — Changsha, China (enrolling)
• Zhongnan Hospital of Wuhan University — Wuhan, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Anyang Tumor Hospital — Anyang, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, China (enrolling)
• No. 1 Bandong Road, Gongshu District, Hangzhou — Hangzhou, China (enrolling)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, China (enrolling)
• The First Affiliated Hospital of Ustc — Hefei, China (enrolling)
• Jilin Cancer Hospital — Changchun, China (enrolling)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (enrolling)
• The Second Affiliated Hospital of Nanchang University — Nanchang, China (enrolling)
• Shandong Cancer Hospital & Institute — Jinan, Shandong, China (enrolling)
• Xiangya Hospital Central South University — Changsha, Hunan, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, China (enrolling)
• Shanxi Cancer hospital — Taiyuan, China (enrolling)
• Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic — Tbilisi, K'alak'i T'bilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

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