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)
Tifcemalimab injectiontoripalimab injectionPlacebo for TifcemalimabPlacebo for toripalimab
Tifcemalimab injection: 200mg once every 3weeks
toripalimab injection: 240mg once every 3 weeks
Placebo for Tifcemalimab: every 3weeks
Placebo for toripalimab: every 3weeks
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be enrolled:
1. Male or female with age ≥ 18 years old at the time of informed consent.
2. 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.
3. 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.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .
6. Adequate organ function
7. Female patients of childbearing potential and male patients whose partners are women of childbearing age.
8. 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.
1. Mixed SCLC and non-small cell lung cancer (NSCLC).
2. Received sequential chemoradiotherapy for LS-SCLC.
3. 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.
4. Patients with active autoimmune disease, history of autoimmune disease.
5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
7. 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).
8. 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.
9. Women who are pregnant or breastfeeding.
Primary outcome measure(s)
Overall survival (OS) — up to 3years To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by OS
OS — up to 3years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS"
Progression-free survival (PFS) — up to 2years To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS.
Progression-free survival (PFS) — up to 2years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS and BIRC-assessed PFS.
Trial sites (76)
Facility
City
Region
Status
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Xiangya Hospital Central South University
Changsha
Hunan
Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Shandong Cancer Hospital & Institute
Jinan
Shandong
Recruiting
Anyang Tumor Hospital
Anyang
China
Recruiting
Beijing Cancer Hospital
Beijing
China
Not Yet Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
China
Recruiting
Jilin Cancer Hospital
Changchun
China
Recruiting
Hunan Cancer Hospital
Changsha
China
Recruiting
Sichuan cancer hospital
Chengdu
China
Not Yet Recruiting
Chongqing University Cancer Hospital
Chongqing
China
Recruiting
Peking University Shenzhen Hospital
Guangdong
China
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
China
Recruiting
No. 1 Bandong Road, Gongshu District, Hangzhou
Hangzhou
China
Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
China
Recruiting
The First Affiliated Hospital of Ustc
Hefei
China
Recruiting
Henan Cancer Hospital
Henan
China
Not Yet Recruiting
Affiliated Hospital of Jining Medical University
Jining
China
Not Yet Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
China
Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
China
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
China
Not Yet Recruiting
Fudan University Shanghai Cancer Center
Shanghai
China
Not Yet Recruiting
Liaoning cancer hospital
Shenyang
China
Not Yet Recruiting
Shanxi Cancer hospital
Taiyuan
China
Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou
China
Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
China
Recruiting
Hubei Cancer Hospital (Hubei Cancer Research Institute)
Wuhan
China
Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
China
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
China
Not Yet Recruiting
General Hospital of Ningxia Medical University
Yinchuan
China
Recruiting
ISR-GEO Med Res Clin Healthycore
Tbilisi
K'alak'i T'bilisi
Recruiting
Ltd New Hospitals
Tbilisi
K'alak'i T'bilisi
Recruiting
Multprofil Clinic Consilium Medulla
Tbilisi
K'alak'i T'bilisi
Recruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi
K'alak'i T'bilisi
Recruiting
"TIM - Tbilisi Institute of Medicine" LTD
Tbilisi
Georgia
Not Yet Recruiting
ICO-Institute of Clinical Oncology - Hospital
Tbilisi
Georgia
Recruiting
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi
Georgia
Recruiting
LTD "New Hospitals"
Tbilisi
Georgia
Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Netherlands
Not Yet Recruiting
+ 36 more sites — see the full list on the official registry below.
More Shanghai Junshi Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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