Actively Recruiting
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)
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2024-06-21
756
Participants Needed
156
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- Confirmed limited-stage small cell lung cancer using VALSG staging criteria
- For TNM Stage I or II disease, medically inoperable or refusal of surgery
- Completed chemoradiotherapy with 4 cycles of carboplatin or cisplatin plus etoposide and appropriate radiation doses
- Begin study treatment within 42 days after last chemotherapy dose
- Achieved complete response, partial response, or stable disease after chemoradiotherapy without progression
- ECOG performance status score of 0 or 1
- Adequate organ function
- Women of childbearing potential and male partners of such women
- Willing to sign informed consent and comply with study procedures
You will not qualify if you...
- Mixed small cell lung cancer and non-small cell lung cancer
- Received sequential chemoradiotherapy for LS-SCLC
- Failure to recover from prior cancer therapy toxicity worse than CTCAE Grade 1 (except alopecia)
- Active or history of autoimmune disease
- History of immunodeficiency including HIV or organ/bone marrow transplantation
- History of interstitial lung disease or pneumonitis (except Grade 1 radiation pneumonitis without corticosteroid treatment)
- Active hepatitis B or C infection
- Any other malignancy diagnosed before study treatment except low-risk treated cancers
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 156 locations
1
Banner MD Anderson Cancer Center
Goodyear, Arizona, United States, 85338
Not Yet Recruiting
2
Banner University Medical Center
Tucson, Arizona, United States, 85713
Not Yet Recruiting
3
Genesis Cancer and Blood Institute (Hot Springs, AR)
Hot Springs, Arkansas, United States, 05001
Not Yet Recruiting
4
SCRI Nashville
Davis, California, United States, 95616
Not Yet Recruiting
5
Zangmeister Cancer Center (Columbus, OH)
Los Angeles, California, United States, 43219
Not Yet Recruiting
6
Los Angeles Hematology Oncology
Los Angeles, California, United States, 90033
Not Yet Recruiting
7
University of Southern California Norris Comprehensive Cancer
Los Angeles, California, United States, 90033
Actively Recruiting
8
Florida Cancer Specialists Pan Handle
Fort Myers, Florida, United States, 32310
Not Yet Recruiting
9
Florida Cancer Specialists South
Fort Myers, Florida, United States, 33908
Not Yet Recruiting
10
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
Miami, Florida, United States, 33173
Not Yet Recruiting
11
Mid-Florida Hematology Oncology
Orange City, Florida, United States, 55905
Actively Recruiting
12
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States, 30060
Not Yet Recruiting
13
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
Louisville, Kentucky, United States, 40241
Not Yet Recruiting
14
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
Actively Recruiting
15
Dana Farber Cancer Institute-Hematology/Oncology
Boston, Massachusetts, United States, 461099
Not Yet Recruiting
16
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Not Yet Recruiting
17
Henry Ford Health System
Detroit, Michigan, United States, 48202
Not Yet Recruiting
18
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49502
Actively Recruiting
19
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63101
Not Yet Recruiting
20
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Not Yet Recruiting
21
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 07101
Not Yet Recruiting
22
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
New York, New York, United States, 11776
Not Yet Recruiting
23
University of Stony Brook
Stony Brook, New York, United States, 11794
Not Yet Recruiting
24
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, United States, 97391
Actively Recruiting
25
Oncology Associates Of Oregon, P.C.
Eugene, Oregon, United States, 97401
Not Yet Recruiting
26
Oregon Health and Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
27
Millennium Physicians - Oncology
Houston, Texas, United States, 77090
Actively Recruiting
28
Texas Oncology, P.A. - Oncology
Tyler, Texas, United States, 97402
Not Yet Recruiting
29
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22030
Not Yet Recruiting
30
Algemeen Ziekenhuis Klina
Antwerp, Belgium
Not Yet Recruiting
31
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Belgium
Not Yet Recruiting
32
AZ Groeningen
Kortrijk, Belgium
Not Yet Recruiting
33
Jessa Ziekenhuis - Campus Virga Jesse
Limbourg, Belgium
Not Yet Recruiting
34
CHU UCL Namur - Site Sainte-Elisabeth
Namur, Belgium
Not Yet Recruiting
35
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
36
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
37
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
38
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
39
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Actively Recruiting
40
Anyang Tumor Hospital
Anyang, China
Actively Recruiting
41
Beijing Cancer Hospital
Beijing, China
Not Yet Recruiting
42
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
43
Jilin Cancer Hospital
Changchun, China
Actively Recruiting
44
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
45
Sichuan cancer hospital
Chengdu, China
Not Yet Recruiting
46
Chongqing University Cancer Hospital
Chongqing, China
Actively Recruiting
47
Peking University Shenzhen Hospital
Guangdong, China
Not Yet Recruiting
48
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
49
No. 1 Bandong Road, Gongshu District, Hangzhou
Hangzhou, China
Actively Recruiting
50
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
51
The First Affiliated Hospital of Ustc
Hefei, China
Actively Recruiting
52
Henan Cancer Hospital
Henan, China
Not Yet Recruiting
53
Affiliated Hospital of Jining Medical University
Jining, China
Not Yet Recruiting
54
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
55
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
56
The Affiliated Hospital of Qingdao University
Qingdao, China
Not Yet Recruiting
57
Fudan University Shanghai Cancer Center
Shanghai, China
Not Yet Recruiting
58
Liaoning cancer hospital
Shenyang, China
Not Yet Recruiting
59
Shanxi Cancer hospital
Taiyuan, China
Actively Recruiting
60
Taizhou Hospital of Zhejiang Province
Taizhou, China
Not Yet Recruiting
61
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
62
Hubei Cancer Hospital (Hubei Cancer Research Institute)
Wuhan, China
Actively Recruiting
63
Zhongnan Hospital of Wuhan University
Wuhan, China
Actively Recruiting
64
The First Affiliated Hospital of Xiamen University
Xiamen, China
Not Yet Recruiting
65
General Hospital of Ningxia Medical University
Yinchuan, China
Actively Recruiting
66
Centre Hospitalier Universitaire D Angers
Angers, France
Not Yet Recruiting
67
Institut Bergonie
Bordeaux, France
Not Yet Recruiting
68
Centre Hospitalier Intercommunal De Créteil
Créteil, France
Not Yet Recruiting
69
CHU de Grenoble
Grenoble, France
Not Yet Recruiting
70
Centre Leon Berard - departement d'oncologie medicale
Lyon, France
Not Yet Recruiting
71
Centre de Cancérologie du Grand Montpellier
Montpellier, France
Not Yet Recruiting
72
Hopital Arnaud De Villeneuve - Oncologie/Pneumologie
Montpellier, France
Not Yet Recruiting
73
Hopital Haut-Leveque - Maladies respiratoires
Pessac, France
Not Yet Recruiting
74
Chu Hôpitaux De Rouen
Rouen, France
Not Yet Recruiting
75
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, France
Not Yet Recruiting
76
Chru De Tours
Tours, France
Not Yet Recruiting
77
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
78
"TIM - Tbilisi Institute of Medicine" LTD
Tbilisi, Georgia
Not Yet Recruiting
79
ICO-Institute of Clinical Oncology - Hospital
Tbilisi, Georgia
Actively Recruiting
80
ISR-GEO Med Res Clin Healthycore
Tbilisi, Georgia
Actively Recruiting
81
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia
Actively Recruiting
82
LTD "New Hospitals"
Tbilisi, Georgia
Actively Recruiting
83
Ltd New Hospitals
Tbilisi, Georgia
Actively Recruiting
84
Multprofil Clinic Consilium Medulla
Tbilisi, Georgia
Actively Recruiting
85
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia
Actively Recruiting
86
Evangelische Lungenklinik Berlin
Berlin, Germany
Not Yet Recruiting
87
Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie
Esslingen am Neckar, Germany
Not Yet Recruiting
88
Univeristätsklinikum Giessen und Marburg GmbH
Giessen, Germany
Not Yet Recruiting
89
Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat
Kassel, Germany
Not Yet Recruiting
90
Gemeinschaftspraxis fuer Haematologie und Onkologie
Münster, Germany
Not Yet Recruiting
91
Universitätsklinikum Regensburg
Regensburg, Germany
Not Yet Recruiting
92
PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, Italy
Not Yet Recruiting
93
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
Cesena, Italy
Not Yet Recruiting
94
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Not Yet Recruiting
95
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod
Modena, Italy
Not Yet Recruiting
96
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
Not Yet Recruiting
97
Iov, Irccs
Padova, Italy
Not Yet Recruiting
98
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, Italy
Not Yet Recruiting
99
AO S. Camillo-Forlanini
Roma, Italy
Not Yet Recruiting
100
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST
Roma, Italy
Not Yet Recruiting
101
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Not Yet Recruiting
102
Rijnstate Ziekenhuis
Arnhem, Netherlands
Not Yet Recruiting
103
Erasmus Medisch Centrum
Rotterdam, Netherlands
Not Yet Recruiting
104
Isala Klinieken Zwolle
Zwolle, Netherlands
Not Yet Recruiting
105
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Not Yet Recruiting
106
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, Poland
Not Yet Recruiting
107
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow
Poznan, Poland
Not Yet Recruiting
108
Instytut Gruzlicy i Chorob Pluc
Warsaw, Poland
Not Yet Recruiting
109
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, Romania
Not Yet Recruiting
110
Medisprof
Cluj-Napoca, Romania
Not Yet Recruiting
111
Centrul de Oncologie Sf. Nectarie
Craiova, Romania
Not Yet Recruiting
112
Oncolab
Craiova, Romania
Not Yet Recruiting
113
Radiotherapy Center Cluj
Floreşti, Romania
Not Yet Recruiting
114
Oncomed
Timișoara, Romania
Not Yet Recruiting
115
Chungbuk National University Hospital
Cheonju, South Korea
Not Yet Recruiting
116
Seoul National University Bundang Hospital
Seongnam, South Korea
Not Yet Recruiting
117
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Not Yet Recruiting
118
Centro Oncológico de Galicia
A Coruña, Spain
Not Yet Recruiting
119
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Not Yet Recruiting
120
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, Spain
Not Yet Recruiting
121
C.H. Provincial de Castellón
Castellon, Spain
Not Yet Recruiting
122
Complejo Hospitalario de Jaén
Jaén, Spain
Not Yet Recruiting
123
Fundacion Jimenez Diaz
Madrid, Spain
Not Yet Recruiting
124
Hospital Clínico San Carlos
Madrid, Spain
Not Yet Recruiting
125
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
126
Complejo Hospitalario Universitario de Orense
Ourense, Spain
Not Yet Recruiting
127
Hospital Universitario Central de Asturias
Oviedo, Spain
Not Yet Recruiting
128
Hospital Universitario Donostia
San Sebastián, Spain
Not Yet Recruiting
129
Hospital Universitario Virgen De La Macarena
Seville, Spain
Not Yet Recruiting
130
Hospital Arnau De Vilanova De Valencia
Valencia, Spain
Not Yet Recruiting
131
Hospital Universitario Y Politécnico La Fe
Valencia, Spain
Not Yet Recruiting
132
H.C.U.Lozano Blesa
Zaragoza, Spain
Not Yet Recruiting
133
Taipei Veterans General Hospital
Taipei City, Taipei, Taiwan
Actively Recruiting
134
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
Kaohsiung City, Taiwan
Actively Recruiting
135
China Medical University Hospital - Internal Medicine - Taichung
Taichung, Taiwan
Not Yet Recruiting
136
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
137
Chi Mei Hospital, Liouying - Department of Oncology
Tainan, Taiwan
Actively Recruiting
138
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
139
National Taiwan University Hospital - Internal Medicine
Taipei, Taiwan
Not Yet Recruiting
140
Taipei Medical University - Shuang Ho Hospital
Taipei, Taiwan
Actively Recruiting
141
Taipei Medical University - Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
142
Taipei Medical University - WanFang Hospital - Hematology and Oncology
Taipei, Taiwan
Actively Recruiting
143
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
144
Ankara City Hospital
Ankara, Turkey (Türkiye)
Not Yet Recruiting
145
Ankara Liv Hospital
Ankara, Turkey (Türkiye)
Not Yet Recruiting
146
Gulhane Training and Research Hospital - Medical Oncology
Ankara, Turkey (Türkiye)
Not Yet Recruiting
147
Memorial Ankara Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
148
Trakya University Medical Faculty
Edirne, Turkey (Türkiye)
Not Yet Recruiting
149
Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
150
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
151
Ege University Medical Faculty - Pulmonary
Izmir, Turkey (Türkiye)
Not Yet Recruiting
152
İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi
Izmir, Turkey (Türkiye)
Not Yet Recruiting
153
Katip Celebi University Ataturk Research and Training Hospit
Izmir, Turkey (Türkiye)
Not Yet Recruiting
154
Kocaeli University Research and Practice Hospital
Kocaeli, Turkey (Türkiye)
Actively Recruiting
155
Necmettin Erbakan University Meram
Konya, Turkey (Türkiye)
Actively Recruiting
156
Inonu University Turgut Ozal Medical Center
Malatya, Turkey (Türkiye)
Not Yet Recruiting
Research Team
K
kui zhang, Project Directer
CONTACT
K
Kinga Kovacs, Senior Project Leader
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here