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Taking people in ChinaPhase 3

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.

Key facts

Who runs it
Shanghai Junshi Bioscience Co., Ltd.
Where
Anyang, Beijing, Changchun, Changsha, Chengdu, Chongqing, Guangdong, Guangzhou, Hangzhou, Harbin, Hefei, Henan, Jinan, Jining, Nanchang, Qingdao, Shanghai, Shenyang, Taiyuan, Taizhou, Tianjin, Wuhan, Xiamen, and Yinchuan, ChinaSee the 30 sitesAlso in 5 other countries, 44 sites
Trial code
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)
Status
Recruiting
Phase
Phase 3
People taking part
756 people, planned
Started
15 Nov 2023
Expected to end
31 Jul 2029
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tifcemalimab injection
  • toripalimab injection
  • Placebo for Tifcemalimab
  • Placebo for toripalimab
Record updated
27 July 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in China

Also in 5 other countries, 44 sites

  • Anyang Tumor HospitalAnyang, ChinaContact: Anping ZhengTaking people
  • Beijing Cancer HospitalBeijing, ChinaContact: Anhui ShiNot yet recruiting
  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Zhouguang HuiTaking people
  • Jilin Cancer HospitalChangchun, ChinaContact: Ying ChengTaking people
  • Hunan Cancer HospitalChangsha, ChinaContact: Hui WangTaking people
  • Xiangya Hospital Central South UniversityChangsha, ChinaContact: Rongrong ZhouTaking people
  • Sichuan Cancer HospitalChengdu, ChinaContact: Wenxiu YaoNot yet recruiting
  • Chongqing University Cancer HospitalChongqing, ChinaContact: Ying WangTaking people
  • Peking University Shenzhen HospitalGuangdong, ChinaContact: Yajie LiuNot yet recruiting
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Ming ChenTaking people
  • No. 1 Bandong Road, Gongshu District, HangzhouHangzhou, ChinaContact: Yongling JiTaking people
  • The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Wen LiTaking people
  • Harbin Medical University Cancer HospitalHarbin, ChinaContact: Yan YuTaking people
  • The First Affiliated Hospital of USTCHefei, ChinaContact: Dong QianTaking people
  • Henan Cancer HospitalHenan, ChinaContact: Hong GeNot yet recruiting
  • Shandong Cancer Hospital & instituteJinan, ChinaContact: Jinming Yu, MD, PhD,Taking people
  • Affiliated Hospital of Jining Medical UniversityJining, ChinaContact: Shucheng YeNot yet recruiting
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Longhua SunTaking people
  • The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaContact: Anwen LiuTaking people
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaContact: Jing WangNot yet recruiting
  • Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Ming FanNot yet recruiting
  • Liaoning Cancer HospitalShenyang, ChinaContact: Xiaoling LiNot yet recruiting
  • The First Hospital of China Medical UniversityShenyang, ChinaContact: Bo JinTaking people
  • Shanxi Cancer hospitalTaiyuan, ChinaContact: Jie LiTaking people
  • Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaContact: Dongqing LvNot yet recruiting
  • Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaContact: Lujun ZhaoTaking people
  • Hubei Cancer Hospital (Hubei Cancer Research Institute)Wuhan, ChinaContact: Desheng HuTaking people
  • Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Conghua XieTaking people
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Qin LinNot yet recruiting
  • General Hospital of Ningxia Medical UniversityYinchuan, ChinaContact: Ren ZhaoTaking people

About the trial

What the trial wants to find out

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

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.

The 3 groups in the trial

  • Experimental group ATreatment being tested

    Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)

    Treatment: Tifcemalimab injection and toripalimab injection

  • Experimental group BTreatment being tested

    Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)

    Treatment: toripalimab injection and Placebo for Tifcemalimab

  • Placebo group CPlacebo, for comparison

    Placebos for both tifcemalimab and toripalimab (IV)

    Treatment: Placebo for Tifcemalimab and Placebo for toripalimab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests toripalimab with or without tifcemalimab in limited-stage small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 July 2026