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 · NCT06095583 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
60 locations listed.
- Jeroen Bosch Ziekenhuis - 's-Hertogenbosch, Netherlands
- Complexo Hospitalario Universitario A Coruña - A Coruña, Spain
- Ankara City Hospital - Ankara, Turkey (Türkiye)
- Ankara Liv Hospital - Ankara, Turkey (Türkiye)
- Gulhane Training and Research Hospital - Medical Oncology - Ankara, Turkey (Türkiye)
- Memorial Ankara Hospital - Ankara, Turkey (Türkiye)
- Anyang Tumor Hospital - Anyang, China
- Rijnstate Ziekenhuis - Arnhem, Netherlands
- Hospital Universitari Dexeus Grupo Quironsalud - Barcelona, Spain
- Beijing Cancer Hospital - Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, China
- Jilin Cancer Hospital - Changchun, China
- Hunan Cancer Hospital - Changsha, China
- Sichuan cancer hospital - Chengdu, China
- Chongqing University Cancer Hospital - Chongqing, China
- Trakya University Medical Faculty - Edirne, Turkey (Türkiye)
- Peking University Shenzhen Hospital - Guangdong, China
- Sun Yat-sen University Cancer Center - Guangzhou, China
- No. 1 Bandong Road, Gongshu District, Hangzhou - Hangzhou, China
- The Second Affiliated Hospital Zhejiang University School of Medicine - Hangzhou, China
- The First Affiliated Hospital of Ustc - Hefei, China
- Henan Cancer Hospital - Henan, China
- Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology - Istanbul, Turkey (Türkiye)
- Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology - Istanbul, Turkey (Türkiye)
- Ege University Medical Faculty - Pulmonary - Izmir, Turkey (Türkiye)
- İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi - Izmir, Turkey (Türkiye)
- Katip Celebi University Ataturk Research and Training Hospit - Izmir, Turkey (Türkiye)
- Complejo Hospitalario de Jaén - Jaén, Spain
- Affiliated Hospital of Jining Medical University - Jining, China
- No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C. - Kaohsiung City, Taiwan
- Kocaeli University Research and Practice Hospital - Kocaeli, Turkey (Türkiye)
- Necmettin Erbakan University Meram - Konya, Turkey (Türkiye)
- Fundacion Jimenez Diaz - Madrid, Spain
- Hospital Clínico San Carlos - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Inonu University Turgut Ozal Medical Center - Malatya, Turkey (Türkiye)
- The First Affiliated Hospital of Nanchang University - Nanchang, China
- The Second Affiliated Hospital of Nanchang University - Nanchang, China
- The Affiliated Hospital of Qingdao University - Qingdao, China
- Erasmus Medisch Centrum - Rotterdam, Netherlands
- Hospital Universitario Donostia - San Sebastián, Spain
- Fudan University Shanghai Cancer Center - Shanghai, China
- Liaoning cancer hospital - Shenyang, China
- China Medical University Hospital - Internal Medicine - Taichung - Taichung, Taiwan
- Taichung Veterans General Hospital - Taichung, Taiwan
- Chi Mei Hospital, Liouying - Department of Oncology - Tainan, Taiwan
- National Cheng Kung University Hospital - Tainan, Taiwan
- National Taiwan University Hospital - Internal Medicine - Taipei, Taiwan
- Taipei Medical University - Shuang Ho Hospital - Taipei, Taiwan
- Taipei Medical University - Taipei Medical University Hospital - Taipei, Taiwan
- Taipei Medical University - WanFang Hospital - Hematology and Oncology - Taipei, Taiwan
- Shanxi Cancer hospital - Taiyuan, China
- Taizhou Hospital of Zhejiang Province - Taizhou, China
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Taoyuan, Taiwan
- "TIM - Tbilisi Institute of Medicine" LTD - Tbilisi, Georgia
- ICO-Institute of Clinical Oncology - Hospital - Tbilisi, Georgia
- LTD "Israel-Georgian Medical Research Clinic Healthycore" - Tbilisi, Georgia
- LTD "New Hospitals" - Tbilisi, Georgia
- Tianjin Medical University Cancer Institute & Hospital - Tianjin, China
- Hubei Cancer Hospital (Hubei Cancer Research Institute) - Wuhan, China
Showing 60 of 76 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →