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New immunotherapy combo shows promise for tough lung cancer

NCT ID NCT05353257

Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding the immunotherapy drug serplulimab to standard chemoradiotherapy helps people with limited-stage small cell lung cancer live longer and keep the cancer from growing. About 511 participants will receive either serplulimab or a placebo along with chemotherapy and radiation. The study is active but no longer recruiting, and results are awaited.

What this could mean

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

Active substance
Serplulimab (a PD-1 inhibitor, a type of immunotherapy that helps the immune system fight cancer)
What this could lead to
If successful, this could offer a new, more effective treatment option for people with limited-stage small cell lung cancer, potentially extending life and delaying cancer growth.
What could go wrong
This is a phase 3 trial, but results are not yet available. Adding immunotherapy to chemoradiotherapy may increase side effects, and the benefit over standard treatment is not guaranteed.

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

511 people

The number who actually took part.

Started

May 2022

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Male or female, aged ≥18 years when signing the ICF. 2. Histologically diagnosed with SCLC. 3. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses. 4. Major organs are functioning well. Exclusion Criteria: 1. Histologically or cytologically confirmed mixed SCLC. 2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included. 3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy. 4. Patients with other active malignancies within 5 years or at the same time. 5. Subjects with known history of severe allergy to any monoclonal antibody. 6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide. 7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

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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

Contacts and locations

Locations

  • "Sotiria" Thoracic Diseases General Hospital of Athens

    Athens, 115 27, Greece

  • Advent Health Orlando

    Orlando, Florida, 32804, United States

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000, China

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266031, China

  • Anhui Chest Hospital

    Hefei, Anhui, 230031, China

  • Baoji Central Hospital

    Baoji, Shanxi, 721008, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32257, United States

  • Cangzhou People's Hospital

    Cangzhou, Hebei, 061019, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708, United States

  • Clinic of Oncology, Pauls Stradins Clinical university hospital

    Riga, LV-1002, Latvia

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Emad Ibrahim, MD, Inc

    Redlands, California, 92373, United States

  • Fejer County Szent Gyorgy University Teaching Hospital

    Székesfehérvár, 8000, Hungary

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341001, China

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350011, China

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Ganzhou Cancer Hospital

    Ganzhou, Jiangxi, 341005, China

  • General Hospital of Athens "Alexandra"

    Athens, 11528, Greece

  • General University hospital in Prague (Oncology department)

    Prague, 128 08, Czechia

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021, China

  • Gungzhouyikedaxuefushuzhongliuyiyuan

    Guangzhou, Guangzhou, 510095, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Health Partners

    Bloomington, Minnesota, 55425, United States

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hong Kong United Oncology Centre

    Hong Kong, Hong Kong, 999077, China

  • Hospital German Trias i Pujol/ ICO Badalona

    Badalona, 8916, Spain

  • Hospital Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Marques de Valdecilla

    Valdecilla, 39008, Spain

  • Hospital Quironsalud Sagrado Corazón

    Seville, 41013, Spain

  • Hospital St. Jansdal

    Harderwijk, 3844, Netherlands

  • Hospital Universitario Puerta de Hierro

    Madrid, 2822, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Universitario de Badajoz

    Badajoz, 6006, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025, Spain

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Innova Schar Cancer Insitute

    Fairfax, Virginia, 22031, United States

  • Isala Hospital

    Zwolle, 8025, Netherlands

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154007, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000, China

  • Kaiser Permanente Northwest

    Portland, Oregon, 97229, United States

  • Kansas University Mediacal Center

    Fairway, Kansas, 66205, United States

  • Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie

    Vienna, 1210, Austria

  • Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology

    Vienna, 1210, Austria

  • Kliniken der Stadt Cologne GmbH

    Cologne, 51109, Germany

  • Klinikum Klagenfurt am Worthersee

    Klagenfurt, 9020, Austria

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020, Austria

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Linyi Tumor Hospital

    Linyi, Shandong, 276002, China

  • Lung and Chest Cancer Clinic, National Institute of Oncology

    Warsaw, 02-781, Poland

  • Lutheran Medical Center - Cancer Centers of Colorado

    Golden, Colorado, 80401, United States

  • MedPoloniaSp. z o.o.

    Poznan, 60-693, Poland

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763, United States

  • Millennium Research & Clinical Development

    Houston, Texas, 77090, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Napa Research

    Pompano Beach, Florida, 33064, United States

  • Nemocnice AGEL Ostrava-Vítkovice

    Ostrava-Vitkovice, 703 00, Czechia

  • Nemocnice AGEL Ostrava-Vítkovice

    Ostrava-Vítkovice, 703 00, Czechia

  • New York City Health+HospitalsCorporation Elmhurst Hospital Center

    Elmhurst, New York, 11373, United States

  • Northern Jiangsu people's Hospital

    Yangzhou, Jiangsu, 210008, China

  • Northwell Health

    Queens, New York, 11040, United States

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • OPN-Glendale

    Arcadia, California, 91007, United States

  • OPN-Los Alamitos

    Los Alamitos, California, 90720, United States

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433, United States

  • Pro Research Tools, INC DBA Lumi Research

    Kingwood, Texas, 77339, United States

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • Pulmonary Institute of Torokbalint

    Törökbálint, 2045, Hungary

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong, 999077, China

  • Queen Mary Hospital

    Hong Kong, Hong Kong, 999077, China

  • Renown Health

    Reno, Nevada, 89502, United States

  • Riga East University Hospital, Latvian Oncology Center

    Riga, LV 1079, Latvia

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Shenyang The Tenth People's Hospital

    Shenyang, Liaoning, 110044, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000, China

  • Southern California Permanente Group

    Los Angeles, California, 90034, United States

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510030, China

  • TaiHe Hospital Affiliated Hospital of Hubei University of Medicine

    Shiyan, Hubei, 442000, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000, China

  • Tangshan People's Hospital

    Tangshan, Hebei, 063001, China

  • The 1st Affiliated Hospital of WMU

    Wenzhou, Zhejiang, 325000, China

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099, China

  • The First Affiliated Hospital of Chongqing Medical

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510000, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First People's Hospital Of Changde City

    Changde, Hunan, 415000, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541100, China

  • The Second People's Hospital Of Yibin

    Sichuan, Yibin, 644000, China

  • The Second Xiangya Hospita

    Changsha, Hunan, 410008, China

  • The University of Texas - Hope Cancer Center

    Tyler, Texas, 75701, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030, China

  • Tricounty Hematology and Oncology Associates

    Massillon, Ohio, 44646, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University Hospital Brno

    Brno, 625 00, Czechia

  • University Hospital Brno (Clinic For Lung Diseases and Tuberculosis)

    Brno, 625 00, Czechia

  • University Hospital La Fe

    Valencia, 46026, Spain

  • University Hospital Motol

    Prague, 150 06, Czechia

  • University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)

    Prague, Czechia

  • University Hospital Olomouc (Oncology Clinic)

    Olomouc, 775 20, Czechia

  • University Hospital Ostrava

    Ostrava-Poruba, Czechia

  • University Hospital Ostrava (oncology department)

    Ostrava-Poruba, 570852, Czechia

  • University hospital Schleswig-Holstein

    Travemünde, 23538, Germany

  • Wenzhou University Hospital

    Wenzhou, Shanghai Municipality, 200032, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410013, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000, China

  • Yuhang Branch of the First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005, China

  • Zhongnan hospital of wuhan university

    Wuhan, Hubei, 430071, China

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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