Can a double immune attack keep lung cancer at bay?

NCT ID NCT06095583

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding one or two immune-boosting antibodies—toripalimab alone or combined with tifcemalimab—after standard chemoradiotherapy can help people with limited-stage small cell lung cancer live longer without the cancer growing. About 756 participants who have not progressed after chemoradiotherapy will receive either the drug combination, toripalimab alone, or placebos. The study aims to see if these immune therapies can improve survival and delay cancer recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: toripalimab and tifcemalimab, two experimental immune-boosting antibodies
What this could lead to: If successful, this combination could offer a new consolidation treatment to help prevent lung cancer from returning after initial chemoradiotherapy.
What could go wrong: This is an early-phase trial in a specific cancer type, and neither drug is approved for this use. Immune-related side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 756 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Limited-stage small cell lung cancer (LS-SCLC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

76 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

"TIM - Tbilisi Institute of Medicine" LTD
NOT_YET_RECRUITING

Tbilisi, Georgia
Affiliated Hospital of Jining Medical University
NOT_YET_RECRUITING

Jining, China
Ankara City Hospital
NOT_YET_RECRUITING

Ankara, Turkey (Türkiye)
Ankara Liv Hospital
NOT_YET_RECRUITING

Ankara, Turkey (Türkiye)
Anyang Tumor Hospital
RECRUITING

Anyang, China
Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology
NOT_YET_RECRUITING

Istanbul, Turkey (Türkiye)
Beijing Cancer Hospital
NOT_YET_RECRUITING

Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING

Beijing, China
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
RECRUITING

Taoyuan, Taiwan
Chi Mei Hospital, Liouying - Department of Oncology
RECRUITING

Tainan, Taiwan
China Medical University Hospital - Internal Medicine - Taichung
NOT_YET_RECRUITING

Taichung, Taiwan
Chongqing University Cancer Hospital
RECRUITING

Chongqing, China
Complejo Hospitalario de Jaén
NOT_YET_RECRUITING

Jaén, Spain
Complexo Hospitalario Universitario A Coruña
NOT_YET_RECRUITING

A Coruña, Spain
Ege University Medical Faculty - Pulmonary
NOT_YET_RECRUITING

Izmir, Turkey (Türkiye)
Erasmus Medisch Centrum
NOT_YET_RECRUITING

Rotterdam, Netherlands
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING

Shanghai, China
Fundacion Jimenez Diaz
NOT_YET_RECRUITING

Madrid, Spain
General Hospital of Ningxia Medical University
RECRUITING

Yinchuan, China
Gulhane Training and Research Hospital - Medical Oncology
NOT_YET_RECRUITING

Ankara, Turkey (Türkiye)
H.C.U.Lozano Blesa
NOT_YET_RECRUITING

Zaragoza, Spain
Harbin Medical University Cancer Hospital
RECRUITING

Harbin, Heilongjiang, China
Henan Cancer Hospital
NOT_YET_RECRUITING

Henan, China
Hospital Clínico San Carlos
NOT_YET_RECRUITING

Madrid, Spain
Hospital Universitari Dexeus Grupo Quironsalud
NOT_YET_RECRUITING

Barcelona, Spain
Hospital Universitario Donostia
NOT_YET_RECRUITING

San Sebastián, Spain
Hospital Universitario La Paz
NOT_YET_RECRUITING

Madrid, Spain
Hospital Unviersitario Miguel Servet
RECRUITING

Zaragoza, Spain
Hubei Cancer Hospital (Hubei Cancer Research Institute)
RECRUITING

Wuhan, China
Hunan Cancer Hospital
RECRUITING

Changsha, China
ICO-Institute of Clinical Oncology - Hospital
RECRUITING

Tbilisi, Georgia
ISR-GEO Med Res Clin Healthycore
RECRUITING

Tbilisi, K'alak'i T'bilisi, Georgia
Inonu University Turgut Ozal Medical Center
NOT_YET_RECRUITING

Malatya, Turkey (Türkiye)
Isala Klinieken Zwolle
NOT_YET_RECRUITING

Zwolle, Netherlands
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
NOT_YET_RECRUITING

Istanbul, Turkey (Türkiye)
Jeroen Bosch Ziekenhuis
NOT_YET_RECRUITING

's-Hertogenbosch, Netherlands
Jilin Cancer Hospital
RECRUITING

Changchun, China
Katip Celebi University Ataturk Research and Training Hospit
NOT_YET_RECRUITING

Izmir, Turkey (Türkiye)
Kocaeli University Research and Practice Hospital
RECRUITING

Kocaeli, Turkey (Türkiye)
LTD "Israel-Georgian Medical Research Clinic Healthycore"
RECRUITING

Tbilisi, Georgia
LTD "New Hospitals"
RECRUITING

Tbilisi, Georgia
Liaoning cancer hospital
NOT_YET_RECRUITING

Shenyang, China
Ltd New Hospitals
RECRUITING

Tbilisi, K'alak'i T'bilisi, Georgia
Memorial Ankara Hospital
RECRUITING

Ankara, Turkey (Türkiye)
Multprofil Clinic Consilium Medulla
RECRUITING

Tbilisi, K'alak'i T'bilisi, Georgia
National Cheng Kung University Hospital
RECRUITING

Tainan, Taiwan
National Taiwan University Hospital - Internal Medicine
NOT_YET_RECRUITING

Taipei, Taiwan
Necmettin Erbakan University Meram
RECRUITING

Konya, Turkey (Türkiye)
No. 1 Bandong Road, Gongshu District, Hangzhou
RECRUITING

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

Kaohsiung City, Taiwan
Peking University Shenzhen Hospital
NOT_YET_RECRUITING

Guangdong, China
Rijnstate Ziekenhuis
NOT_YET_RECRUITING

Arnhem, Netherlands
Shandong Cancer Hospital & Institute
RECRUITING

Jinan, Shandong, China
Shanxi Cancer hospital
RECRUITING

Taiyuan, China
Sichuan cancer hospital
NOT_YET_RECRUITING

Chengdu, China
Sun Yat-sen University Cancer Center
RECRUITING

Guangzhou, China
Taichung Veterans General Hospital
RECRUITING

Taichung, Taiwan
Taipei Medical University - Shuang Ho Hospital
RECRUITING

Taipei, Taiwan
Taipei Medical University - Taipei Medical University Hospital
RECRUITING

Taipei, Taiwan
Taipei Medical University - WanFang Hospital - Hematology and Oncology
RECRUITING

Taipei, Taiwan
Taipei Veterans General Hospital
RECRUITING

Taipei City, Taipei, Taiwan
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING

Taizhou, China
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
RECRUITING

Tbilisi, K'alak'i T'bilisi, Georgia
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING

Qingdao, China
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, China
The First Affiliated Hospital of Ustc
RECRUITING

Hefei, China
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING

Xiamen, China
The First Hospital of China Medical University
RECRUITING

Shenyang, Liaoning, China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING

Hangzhou, China
The Second Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, China
Trakya University Medical Faculty
NOT_YET_RECRUITING

Edirne, Turkey (Türkiye)
Xiangya Hospital Central South University
RECRUITING

Changsha, Hunan, China
Zhongnan Hospital of Wuhan University
RECRUITING

Wuhan, China
İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi
NOT_YET_RECRUITING

Izmir, Turkey (Türkiye)

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