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New lung cancer combo shows promise in Head-to-Head trial

NCT ID NCT05468489

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new drug, serplulimab, combined with chemotherapy, against an existing drug, atezolizumab, also with chemotherapy, for people with extensive-stage small cell lung cancer who haven't had treatment before. The goal is to see which combination works better at controlling the cancer and improving survival. About 200 adults in the US are taking part.

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 200 people

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

Started

Nov 2022

Expected to finish

Dec 2027

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: Voluntary participation in clinical studies. Male or female aged ≥ 18 years at the time of signing the ICF. Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system). No prior systemic therapy for ES-SCLC. At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization. Major organs are functioning well. Every effort should be made to provide tumor tissues for the determination of PD-L1 expression. An ECOG PS score of 0 or 1. An expected survival ≥ 12 weeks. Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment. Participant must keep contraception. Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC. Known history of severe allergy to any monoclonal antibody. Known hypersensitivity to carboplatin or etoposide. Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia. Pregnant or breastfeeding females. Patients with a known history of psychotropic drug abuse or drug addiction. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

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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.

Extensive-stage small-cell lung cancer

Contacts and locations

Locations

  • Accellacare of Duly

    Tinley Park, Illinois, 60487, United States

  • Advanced Cancer Treatment Centers

    Brooksville, Florida, 34613, United States

  • Advanced Research

    Tamarac, Florida, 33321, United States

  • Alabama Oncology

    Birmingham, Alabama, 35223, United States

  • American Oncology Network Vista Oncology Division

    Olympia, Washington, 98502, United States

  • Arizona Clinical Research Center (ACRC)

    Tucson, Arizona, 85715, United States

  • Aultman Cancer Center

    Canton, Ohio, 44710, United States

  • BRCR Global

    Plantation, Florida, 33322, United States

  • Banner MD Anderson Cancer Center (BMDACC)

    Greeley, Colorado, 80631, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • CHRISTUS Institute for Innovation & Advanced Clinical Care

    Corpus Christi, Texas, 78404, United States

  • CHRISTUS St. Frances Cabrini Cancer Center

    Alexandria, Louisiana, 71301, United States

  • Cancer Center of Decatur

    Decatur, Illinois, 62526, United States

  • Cancer Center of Kansas

    Wichita, Kansas, 67214, United States

  • Cancer Specialists North Florida

    Jacksonville, Florida, 32256, United States

  • CharterCARE (Roger Williams)

    Providence, Rhode Island, 02908, United States

  • City of Hope - Phoenix

    Goodyear, Arizona, 85338, United States

  • City of Hope- Chicago

    Chicago, Illinois, 60099, United States

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708, United States

  • Compassionate Care Research Group

    Fountain Valley, California, 92708, United States

  • DHR Research

    Edinburg, Texas, 78539, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Elmhurst (BRANY site)

    Elmhurst, New York, 11373, United States

  • Florida Cancer Affiliates- (Ocala Oncology - Main)

    Ocala, Florida, 34473, United States

  • Froedtert Hospital- Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Great Lakes Cancer Care (Kaleida Health)

    Williamsville, New York, 14221, United States

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401, United States

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Henry Ford Health Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410, United States

  • Kaiser Permanente Research (Southern California)

    Los Angeles, California, 90034, United States

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805, United States

  • Lake Regional

    Osage Beach, Missouri, 65065, United States

  • Los Angeles Cancer Network

    Glendale, California, 91204, United States

  • Lumi Research

    Kingwood, Texas, 77339, United States

  • MD Anderson- North Colorado Medical Center

    Greeley, Colorado, 80631, United States

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763, United States

  • MidAmerica Division Inc., c/o Research Medical Center

    Kansas City, Missouri, 64132, United States

  • Millennium Research and Clinical Development

    Houston, Texas, 77090, United States

  • Monument Health

    Rapid City, South Dakota, 57701, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida, 33140, United States

  • Napa Research

    Pompano Beach, Florida, 33064, United States

  • North Mississippi Medical Center Hematology and Oncology Clinic

    Tupelo, Mississippi, 38801, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Northwest Cancer Centers

    Dyer, Indiana, 46311, United States

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • OPN - Oncology Physician Network

    Los Alamitos, California, 90720, United States

  • Pikeville Hospital

    Pikeville, Kentucky, 41501, United States

  • Pontchartrain Cancer Center

    Hammond, Louisiana, 70433, United States

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Regional Cancer Care Associates LLC RCCA

    Freehold, New Jersey, 03756, United States

  • Renown Health

    Reno, Nevada, 89502, United States

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102, United States

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794, United States

  • Summa Health

    Akron, Ohio, 44304, United States

  • The University of Texas Health Science Center at Tyler/HOPE Cancer Center

    Tyler, Texas, 75701, United States

  • Tricounty Hematology and Oncology Associates

    Massillon, Ohio, 44646, United States

  • UC Davis

    Sacramento, California, 95817, United States

  • UCHealth Memorial Hospital North

    Colorado Springs, Colorado, 80920, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68106, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26505, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.