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Limited-stage Small Cell Lung Cancer (LS-SCLC)Phase 3NCT06095583

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)

A Phase 3 study testing Tifcemalimab injection and toripalimab injection in people with Limited-stage Small Cell Lung Cancer (LS-SCLC), run by Shanghai Junshi Bioscience Co., Ltd. at 76 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tifcemalimab injection and toripalimab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
756 participants
Where
76 sitesin 6 countries
Study dates
15 Nov 2023to 31 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

76 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

kui zhang, Project Directer contact

08618168028925

kui_zhang@junshipharma.com

Kinga Kovacs, Senior Project Leader contact

+ 31 6 45974346

Kinga.Kovacs@parexel.com

76 sites in 6 countries

China31 sites, 31 recruiting

  • Anyang Tumor Hospital

    Anyang

    Anping Zheng

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Anhui Shi

    Not yet recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Zhouguang Hui

    Recruiting

  • Jilin Cancer Hospital

    Changchun

    Ying Cheng

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Rongrong Zhou

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Hui Wang

    Recruiting

  • Sichuan cancer hospital

    Chengdu

    Wenxiu Yao

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Ying Wang

    Recruiting

  • Peking University Shenzhen Hospital

    Guangdong

    Yajie Liu

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Ming Chen

    Recruiting

  • No. 1 Bandong Road, Gongshu District, Hangzhou

    Hangzhou

    Yongling Ji

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

    Wen Li

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Yan Yu

    Recruiting

  • The First Affiliated Hospital of Ustc

    Hefei

    Dong Qian

    Junqiang Zhang

    Recruiting

  • Henan Cancer Hospital

    Henan

    Hong Ge

    Not yet recruiting

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong

    Jinming Yu, MD, PhD,, 86 13806406293, sdyujinming@126.com

    Jinming Yu, MD, PhD,

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining

    Shucheng Ye

    Not yet recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Anwen Liu

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Longhua Sun

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Anwen Liu

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Jing Wang

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Ming Fan

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Bo Jin

    Recruiting

  • Liaoning cancer hospital

    Shenyang

    Xiaoling Li

    Not yet recruiting

  • Shanxi Cancer hospital

    Taiyuan

    Jie Li

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou

    Dongqing Lv

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Lujun Zhao

    Recruiting

  • Hubei Cancer Hospital (Hubei Cancer Research Institute)

    Wuhan

    Desheng Hu

    Yi Peng

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan

    Conghua Xie

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Qin Lin

    Not yet recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan

    Ren Zhao

    Recruiting

Other trials in China

Turkey (Türkiye)13 sites, 13 recruiting

  • Ankara City Hospital

    Ankara

    Mehmet Sendur

    Not yet recruiting

  • Ankara Liv Hospital

    Ankara

    Saadettin Kilickap

    Not yet recruiting

  • Gulhane Training and Research Hospital - Medical Oncology

    Ankara

    Nuri Karadurmus

    Not yet recruiting

  • Memorial Ankara Hospital

    Ankara

    Umut Demirici

    Recruiting

  • Trakya University Medical Faculty

    Edirne

    Muhammet Hacioglu

    Not yet recruiting

  • Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology

    Istanbul

    Deniz Tural

    Not yet recruiting

  • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

    Istanbul

    Mahmut Gumus

    Not yet recruiting

  • Ege University Medical Faculty - Pulmonary

    Izmir

    Tuncay Goksel

    Not yet recruiting

  • İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi

    Izmir

    Arslan Cagatay

    Not yet recruiting

  • Katip Celebi University Ataturk Research and Training Hospit

    Izmir

    Ahmet Alacacioglu

    Not yet recruiting

  • Kocaeli University Research and Practice Hospital

    Kocaeli

    Devrim Cabuk

    Recruiting

  • Necmettin Erbakan University Meram

    Konya

    Mehmet Artac

    Recruiting

  • Inonu University Turgut Ozal Medical Center

    Malatya

    Hakan Harputluoglu

    Not yet recruiting

Other trials in Turkey (Türkiye)

Taiwan11 sites, 11 recruiting

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

    Kaohsiung City

    Chin-Chou 金洲 Wang 王

    Recruiting

  • China Medical University Hospital - Internal Medicine - Taichung

    Taichung

    Te-Chun 德椿 Hsia 夏

    Not yet recruiting

  • Taichung Veterans General Hospital

    Taichung

    Tsung-Ying 宗穎 Yang 楊

    Recruiting

  • Chi Mei Hospital, Liouying - Department of Oncology

    Tainan

    Wan-Chen婉真 Kao高

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Chun Hui Lee

    Recruiting

  • National Taiwan University Hospital - Internal Medicine

    Taipei

    Chih-Hsin 志新 Yang 楊

    Not yet recruiting

  • Taipei Medical University - Shuang Ho Hospital

    Taipei

    Kang-Yun 岡遠 Lee 李

    Recruiting

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei

    Shih-Hsin 世欣 Hsiao 蕭

    Recruiting

  • Taipei Medical University - WanFang Hospital - Hematology and Oncology

    Taipei

    Han-Lin 翰琳 Hsu 許

    Recruiting

  • Taipei Veterans General Hospital

    Taipei City, Taipei

    Yuh-Min Chen

    Recruiting

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan

    Chien-Ying 劍英 Liu 劉

    Recruiting

Other trials in Taiwan

Spain9 sites, 9 recruiting

  • Complexo Hospitalario Universitario A Coruña

    A Coruña

    Maria Rosario Garcia Campelo

    Not yet recruiting

  • Hospital Universitari Dexeus Grupo Quironsalud

    Barcelona

    Ivana Gabriela Sullivan

    Not yet recruiting

  • Complejo Hospitalario de Jaén

    Jaén

    Ana Laura Ortega Granados

    Not yet recruiting

  • Fundacion Jimenez Diaz

    Madrid

    Manuel Dómine Gómez

    Not yet recruiting

  • Hospital Clínico San Carlos

    Madrid

    Jose González Larriba

    Not yet recruiting

  • Hospital Universitario La Paz

    Madrid

    Javier de Castro Carpeño

    Not yet recruiting

  • Hospital Universitario Donostia

    San Sebastián

    Ibone de Elejoste Echebarria

    Not yet recruiting

  • H.C.U.Lozano Blesa

    Zaragoza

    Maria Dolores Isla Casado

    Not yet recruiting

  • Hospital Unviersitario Miguel Servet

    Zaragoza

    Angel Artal Cortés

    Angel Artal Cortés

    Recruiting

Other trials in Spain

Georgia8 sites, 8 recruiting

  • ISR-GEO Med Res Clin Healthycore

    Tbilisi, K'alak'i T'bilisi

    Ekaterine Arkania

    Recruiting

  • Ltd New Hospitals

    Tbilisi, K'alak'i T'bilisi

    Davit Giorgadze

    Recruiting

  • Multprofil Clinic Consilium Medulla

    Tbilisi, K'alak'i T'bilisi

    Tsira Kortua

    Recruiting

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, K'alak'i T'bilisi

    Miranda Gogishvili

    Recruiting

  • "TIM - Tbilisi Institute of Medicine" LTD

    Tbilisi

    Mariam Zhvania

    Not yet recruiting

  • ICO-Institute of Clinical Oncology - Hospital

    Tbilisi

    Vladimer Kuchava

    Recruiting

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi

    Ekaterine Arkania

    Recruiting

  • LTD "New Hospitals"

    Tbilisi

    Davit Giorgadze

    Recruiting

Other trials in Georgia

Netherlands4 sites, 4 recruiting

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

    van Veggel B.A.M.H. (Bianca)

    Not yet recruiting

  • Rijnstate Ziekenhuis

    Arnhem

    Claessens Niels

    Not yet recruiting

  • Erasmus Medisch Centrum

    Rotterdam

    Dumoulin Daphne

    Not yet recruiting

  • Isala Klinieken Zwolle

    Zwolle

    Plomp Peter

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy

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.

Being tested
Tifcemalimab injection, toripalimab injection, Placebo for Tifcemalimab, Placebo for toripalimab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tifcemalimab injectionDrug

    200mg once every 3weeks

  • toripalimab injectionDrug

    240mg once every 3 weeks

  • Placebo for TifcemalimabDrug

    every 3weeks

  • Placebo for toripalimabDrug

    every 3weeks

Study groups in NCT06095583
Study groupRoleWhat they receive
Experimental group AExperimentalTifcemalimab (200 mg intravenous infusion [IV]) and toripalimab (240 mg IV)
Receives: Drug: Tifcemalimab injection; Drug: toripalimab injection
Experimental group BExperimentalPlacebo for tifcemalimab (IV) and toripalimab (240 mg IV)
Receives: Drug: toripalimab injection; Drug: Placebo for Tifcemalimab
Placebo group CPlacebo comparatorPlacebos for both tifcemalimab and toripalimab (IV)
Receives: Drug: Placebo for Tifcemalimab; Drug: Placebo for toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    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

    Measured: up to 3years

  2. OS

    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"

    Measured: up to 3years

  3. Progression-free survival (PFS)

    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.

    Measured: up to 2years

  4. Progression-free survival (PFS)

    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.

    Measured: up to 2years

Secondary outcomes (14)

  1. PFS

    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 Investigator-assessed PFS

    Measured: up to 2years

  2. 1-year OS rate

    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

    Measured: up to 1year

  3. 2-year OS rate

    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

    Measured: up to 2 years

  4. objective response rate (ORR)

    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

    Measured: up to 2 years

  5. disease control rate (DCR)

    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

    Measured: up to 2 years

  6. duration of response (DoR)

    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

    Measured: up to 2years

  7. PFS

    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

    Measured: up to 2 years

  8. 1 year OS rate

    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

    Measured: up to 1 years

  9. 2 year OS rate

    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

    Measured: up to 2 years

  10. ORR

    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

    Measured: up to 2 years

  11. DCR

    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

    Measured: up to 2 years

  12. DoR

    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

    Measured: up to 2 years

  13. Safety（adverse events and abnormal laboratory parameters）

    To compare and evaluate the safety of tifcemalimab and toripalimab (Arm A) 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.

    Measured: up to 2 years

  14. Safety（adverse events and abnormal laboratory parameters）

    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.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start15 Nov 2023
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
756 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06095583
Sponsor's protocol ID
JS004-008-III-SCLC
Status last verified
Jul 2026
First submitted
9 Oct 2023
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tifcemalimab injection and toripalimab injection in people with Limited-stage Small Cell Lung Cancer (LS-SCLC), run by Shanghai Junshi Bioscience Co., Ltd. at 76 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in China, Turkey (Türkiye), Taiwan, Spain, Georgia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact kui zhang, Project Directer (08618168028925, kui_zhang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: up to 3years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06095583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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