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)
- Conditions
- Limited-stage Small Cell Lung Cancer (LS-SCLC)
- Interventions
- Drug: Tifcemalimab injectionDrug: Placebo for Tifcemalimab
- Registration Number
- NCT06095583
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 756
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group B Placebo for Tifcemalimab Placebo for tifcemalimab (IV) and toripalimab (240 mg IV) Placebo group C Placebo for Tifcemalimab Placebos for both tifcemalimab and toripalimab (IV) Experimental group A toripalimab injection Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV) Experimental group B toripalimab injection Placebo for tifcemalimab (IV) and toripalimab (240 mg IV) Placebo group C Placebo for toripalimab Placebos for both tifcemalimab and toripalimab (IV) Experimental group A Tifcemalimab injection Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)
- Primary Outcome Measures
Name Time Method 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"
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
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.
- Secondary Outcome Measures
Name Time Method 2 year OS rate up to 2 years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 2-year OS rate
ORR up to 2 years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by ORR
DoR up to 2 years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by DoR
1-year OS rate up to 1year 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 1-year OS rate
objective response rate (ORR) up to 2 years 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 ORR
2-year OS rate up to 2 years 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 2-year OS rate
disease control rate (DCR) up to 2 years 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 DCR
1 year OS rate up to 1 years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 1-year OS rate
duration of response (DoR) 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 DoR
PFS up to 2 years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by Investigator-assessed PFS
DCR up to 2 years To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by DCR
safety up to 2 years To compare and evaluate the safety of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.
Trial Locations
- Locations (155)
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
🇺🇸Miami, Florida, United States
University of Southern California Norris Comprehensive Cancer
🇺🇸Los Angeles, California, United States
Isala Klinieken Zwolle
🇳🇱Zwolle, Netherlands
Zangmeister Cancer Center (Columbus, OH)
🇺🇸Los Angeles, California, United States
Los Angeles Hematology Oncology
🇺🇸Los Angeles, California, United States
Florida Cancer Specialists South
🇺🇸Fort Myers, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
🇺🇸Marietta, Georgia, United States
Florida Cancer Specialists Pan Handle
🇺🇸Fort Myers, Florida, United States
SCRI Nashville
🇺🇸Davis, California, United States
Dana Farber Cancer Institute-Hematology/Oncology
🇺🇸Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Banner MD Anderson Cancer Center
🇺🇸Goodyear, Arizona, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
🇺🇸New York, New York, United States
Millennium Physicians - Oncology
🇺🇸Houston, Texas, United States
Mid-Florida Hematology Oncology
🇺🇸Orange City, Florida, United States
Washington University School of Medicine - Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Centre Leon Berard - departement d'oncologie medicale
🇫🇷Lyon, France
Institut de Cancérologie de l'Ouest (ICO)
🇫🇷Saint-Herblain, France
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Limbourg, Belgium
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
University of Stony Brook
🇺🇸Stony Brook, New York, United States
Grand Hôpital de Charleroi - Site Notre-Dame
🇧🇪Charleroi, Belgium
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania
🇮🇹Catania, Italy
Centre Hospitalier Intercommunal De Créteil
🇫🇷Créteil, France
Univeristätsklinikum Giessen und Marburg GmbH
🇩🇪Gießen, Germany
Algemeen Ziekenhuis Klina
🇧🇪Antwerpen, Belgium
AZ Groeningen
🇧🇪Kortrijk, Belgium
Jilin Cancer Hospital
🇨🇳Changchun, China
CHU UCL Namur - Site Sainte-Elisabeth
🇧🇪Namur, Belgium
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie
🇩🇪Esslingen, Germany
ISR-GEO Med Res Clin Healthycore
🇬🇪Tbilisi, Georgia
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
🇮🇹Napoli, Italy
Chungbuk National University Hospital
🇰🇷Cheonju, Korea, Republic of
Centrul de Oncologie Sf. Nectarie
🇷🇴Craiova, Romania
Oncolab
🇷🇴Craiova, Romania
Ankara Liv Hospital
🇹🇷Ankara, Turkey
Memorial Ankara Hospital
🇹🇷Ankara, Turkey
İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi
🇹🇷İzmir, Turkey
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Iov, Irccs
🇮🇹Padova, Italy
Hospital Universitario Donostia
🇪🇸San Sebastián, Spain
Instytut Gruzlicy i Chorob Pluc
🇵🇱Warszawa, Poland
Kocaeli University Research and Practice Hospital
🇹🇷Kocaeli, Turkey
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod
🇮🇹Modena, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia
🇮🇹Pavia, Italy
C.H. Provincial de Castellón
🇪🇸Castellón De La Plana, Spain
Gemeinschaftspraxis fuer Haematologie und Onkologie
🇩🇪Münster, Germany
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Ankara City Hospital
🇹🇷Ankara, Turkey
Gulhane Training and Research Hospital - Medical Oncology
🇹🇷Ankara, Turkey
AO S. Camillo-Forlanini
🇮🇹Roma, Italy
Inonu University Turgut Ozal Medical Center
🇹🇷Malatya, Turkey
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Trakya University Medical Faculty
🇹🇷Edirne, Turkey
Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology
🇹🇷Istanbul, Turkey
"TIM - Tbilisi Institute of Medicine" LTD
🇬🇪Tbilisi, Georgia
ICO-Institute of Clinical Oncology - Hospital
🇬🇪Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
🇬🇪Tbilisi, Georgia
LTD "New Hospitals"
🇬🇪Tbilisi, Georgia
Medisprof
🇷🇴Cluj-Napoca, Romania
Radiotherapy Center Cluj
🇷🇴Floreşti, Romania
Oncomed
🇷🇴Timişoara, Romania
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Taipei Medical University - Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
🇨🇳Kaohsiung, Taiwan
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Shandong Cancer Hospital & Institute
🇨🇳Jinan, Shandong, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, China
Sichuan cancer hospital
🇨🇳Chengdu, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, China
The First Affiliated Hospital of Ustc
🇨🇳Hefei, China
Henan Cancer Hospital
🇨🇳Henan, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Liaoning cancer hospital
🇨🇳Shenyang, China
Shanxi Cancer hospital
🇨🇳Taiyuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Hubei Cancer Hospital (Hubei Cancer Research Institute)
🇨🇳Wuhan, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST
🇮🇹Roma, Italy
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
🇹🇷Istanbul, Turkey
Ege University Medical Faculty - Pulmonary
🇹🇷İzmir, Turkey
Katip Celebi University Ataturk Research and Training Hospit
🇹🇷İzmir, Turkey
Necmettin Erbakan University Meram
🇹🇷Konya, Turkey
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Spain
H.C.U.Lozano Blesa
🇪🇸Zaragoza, Spain
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
Genesis Cancer and Blood Institute (Hot Springs, AR)
🇺🇸Hot Springs, Arkansas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oncology Associates Of Oregon, P.C.
🇺🇸Eugene, Oregon, United States
Toledo Clinic Cancer Center - Toledo
🇺🇸Toledo, Ohio, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Anyang Tumor Hospital
🇨🇳Anyang, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Peking University Shenzhen Hospital
🇨🇳Guangdong, China
No. 1 Bandong Road, Gongshu District, Hangzhou
🇨🇳Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, China
Centre Hospitalier Universitaire D Angers
🇫🇷Angers, France
Institut Bergonie
🇫🇷Bordeaux, France
CHU de Grenoble
🇫🇷Grenoble, France
Hopital Arnaud De Villeneuve - Oncologie/Pneumologie
🇫🇷Montpellier, France
Centre de Cancérologie du Grand Montpellier
🇫🇷Montpellier, France
Hopital Haut-Leveque - Maladies respiratoires
🇫🇷Pessac, France
Chu Hôpitaux De Rouen
🇫🇷Rouen, France
Ltd New Hospitals
🇬🇪Tbilisi, Georgia
Chru De Tours
🇫🇷Tours Cedex 9, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Multprofil Clinic Consilium Medulla
🇬🇪Tbilisi, Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
🇬🇪Tbilisi, Georgia
Evangelische Lungenklinik Berlin
🇩🇪Berlin, Germany
Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat
🇩🇪Kassel, Germany
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
🇮🇹Cesena, Italy
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Jeroen Bosch Ziekenhuis
🇳🇱Herzogenbusch, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
🇵🇱Olsztyn, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Białystok, Poland
Centro Oncológico de Galicia
🇪🇸Coruña, Spain
Hospital Universitari Dexeus Grupo Quironsalud
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario A Coruña
🇪🇸Coruña, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Complejo Hospitalario Universitario de Orense
🇪🇸Orense, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Taipei Veterans General Hospital
🇨🇳Taipei city, Taipei, Taiwan
Hospital Universitario Y Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Arnau De Vilanova De Valencia
🇪🇸Valencia, Spain
China Medical University Hospital - Internal Medicine - Taichung
🇨🇳Taichung, Taiwan
National Taiwan University Hospital - Internal Medicine
🇨🇳Taipei, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Chi Mei Hospital, Liouying - Department of Oncology
🇨🇳Tainan, Taiwan
Taipei Medical University - Shuang Ho Hospital
🇨🇳Taipei, Taiwan
Taipei Medical University - WanFang Hospital - Hematology and Oncology
🇨🇳Taipei, Taiwan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow
🇵🇱Poznań, Poland
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
🇺🇸Louisville, Kentucky, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Texas Oncology, P.A. - Oncology
🇺🇸Tyler, Texas, United States