RecruitingPhase IIIEN originalLung cancer

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)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony rak płuc małokomórkowy w ograniczonym stopniu zaawansowania
  • Otrzymanie chemioterapii i radioterapii (co najmniej 4 cykle chemioterapii i dawka promieniowania 60-66 Gy)
  • Brak pogorszenia się choroby po chemioterapii i radioterapii
  • Dobry ogólny stan zdrowia (wynik 0-1 w skali ECOG)
  • Prawidłowe funkcjonowanie organów wewnętrznych
  • Chęć uczestnictwa i podpisanie zgody na badanie

✗ Disqualifies

  • Mieszany typ raka płuc (małokomórkowy i inny)
  • Poprzednia sekwencyjna chemioterapia i radioterapia
  • Brak wyzdrowienia z powikłań poprzedniej terapii
  • Aktywna choroba autoimmunologiczna lub historia choroby autoimmunologicznej

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 27, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (76)

Harbin Medical University Cancer Hospital

Harbin, China

Xiangya Hospital Central South University

Changsha, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

The First Hospital of China Medical University

Shenyang, China

Shandong Cancer Hospital & Institute

Jinan, China

Anyang Tumor Hospital

Anyang, China

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

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

Affiliated Hospital of Jining Medical University

Jining, China

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

Fudan University Shanghai Cancer Center

Shanghai, China

Liaoning cancer hospital

Shenyang, China

Shanxi Cancer hospital

Taiyuan, China

Taizhou Hospital of Zhejiang Province

Taizhou, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Hubei Cancer Hospital (Hubei Cancer Research Institute)

Wuhan, China

Zhongnan Hospital of Wuhan University

Wuhan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

General Hospital of Ningxia Medical University

Yinchuan, China

ISR-GEO Med Res Clin Healthycore

Tbilisi, Georgia

Ltd New Hospitals

Tbilisi, Georgia

Multprofil Clinic Consilium Medulla

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

"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

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Rijnstate Ziekenhuis

Arnhem, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Isala Klinieken Zwolle

Zwolle, Netherlands

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, Spain

Complejo Hospitalario de Jaén

Jaén, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Donostia

San Sebastián, Spain

H.C.U.Lozano Blesa

Zaragoza, Spain

Hospital Unviersitario Miguel Servet

Zaragoza, Spain

Taipei Veterans General Hospital

Taipei City, Taiwan

No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.

Kaohsiung City, Taiwan

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

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan, Taiwan

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)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

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)

Kocaeli University Research and Practice Hospital

Kocaeli, Turkey (Türkiye)

Necmettin Erbakan University Meram

Konya, Turkey (Türkiye)

Inonu University Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

Trial contact

kui zhang, Project Directer

Kinga Kovacs, Senior Project Leader

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/28/2026.

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