New lung cancer combo aims to outperform current standard in consolidation therapy

NCT ID NCT06773910

Disease control Sponsor: SCRI Development Innovations, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests whether a new drug combination (BMS-986489) works better than the current standard (durvalumab) as follow-up treatment after chemoradiation for limited-stage small cell lung cancer. About 250 adults whose cancer hasn't spread widely will be randomly assigned to one of the two treatments. The main goal is to see which approach helps people live longer.

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Study facts

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

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

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

Started

Mar 2025

Expected to finish

Sep 2032

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: * At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A) * Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1 * Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy * Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (computed tomography \[CT\] scan chest/abdomen/pelvis; Appendix B) within 42 days before date of randomization and first dose of study treatment * Chemotherapy should consist of a platinum and IV etoposide. Participants who received at least 3 cycles of chemotherapy will be eligible to participate. * Radiotherapy should be administered per institutional guidelines * Prophylactic cranial irradiation (PCI) may be delivered at the discretion of the Investigator and institutional guidelines. PCI, if applicable, must be conducted after the end of chemoradiotherapy and completed between 14 and 42 days before date of randomization and first dose of study treatment. * Adequate hematologic and organ function * Willingness to abide by protocol defined contraceptive requirements for the duration of the study. Exclusion Criteria: * Small-cell cancer not pulmonary in origin * Large cell neuroendocrine carcinoma * ES-SCLC * Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC * History of severe hypersensitivity reaction to monoclonal antibodies * Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab * Grade ≥2 peripheral neuropathy by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 * Active, prior, or suspected autoimmune disease, including autoimmune neurologic disorders such as paraneoplastic syndrome involving the CNS, peripheral sensory/motor nerves, or neuromuscular junction. Exceptions to this criterion include: * Type 1 diabetes mellitus * Hypothyroidism requiring only hormone replacement * Skin disorders not requiring systemic treatment * Autoimmune conditions not expected to recur during the study * Diseases or conditions requiring chronic systemic corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive therapy within 14 days of starting study treatment. Limited-course (\<2 weeks' duration) oral steroids (10 mg prednisone or equivalent) are permitted. Bronchodilators, inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. * History of solid organ or bone marrow transplantation * History of Grade ≥2 pneumonitis (excepting resolved infective pneumonitis) * Any of the following cardiac criteria, currently or within the last 3 months: * Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block, atrial fibrillation not rate controlled. Certain conditions may be considered through discussion with the Medical Monitor. * Congestive heart failure (New York Heart Association \[NYHA\] \> Grade 2) or classified as Class 3 or 4 by the NYHA Functional Classification (Appendix D) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (Appendix E). Certain conditions may be considered through discussion with the Medical Monitor. * Participants with a left ventricular ejection fraction \<55% or the lower limit of normal of the institutional standard * Uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite optimal medical management * Active coronary artery disease, including unstable or newly diagnosed angina * Myocardial infarction * History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes) * History or current diagnosis of myocarditis * As judged by the Investigator, participants with serious or uncontrolled medical disorders * Presence of other active invasive cancers. Participants with a previously treated malignancy will be eligible to participate if treatment of that malignancy was completed at least 2 years before date of screening and the participants has no evidence of disease. Exceptions to this criterion include appropriately treated basal cell carcinoma of the skin; in situ carcinoma of uterine cervix; localized prostate cancer that has been definitively treated; or other local tumors considered cured by local treatment. * Received sequential chemotherapy and radiotherapy as a definitive treatment for LS-SCLC * Treatment with any of the following: * Any systemic anticancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment * Wide-field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study treatment or has not recovered from side effects of such therapy * Prior systemic treatment for LS-SCLC, with the exception of chemoradiotherapy and PCI * Prior treatment with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand 2 (anti-PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways * Prior treatment with fuc-GM-1 vaccine or targeted agent or similar vaccine targeting ganglioside antigens * Current treatment with immunosuppressive medications * Live attenuated vaccine within 100 days before first dose of study treatment * Major surgery (excluding placement of vascular access) within 4 weeks of date of screening * With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: Participants with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor or Principal Investigator. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol

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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

How to take part

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

The places running it

33 sites. 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.

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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

Baptist Health - Corbin
RECRUITING

Corbin, Kentucky, 40701, United States
Baptist Health - Lexington
RECRUITING

Lexington, Kentucky, 40503, United States
Baptist Health - Louisville
RECRUITING

Louisville, Kentucky, 40207, United States
Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)
RECRUITING

Salem, Virginia, 24153, United States
Cancer Care Centers of Brevard
RECRUITING

Palm Bay, Florida, 32901, United States
Carolina Cancer Research Center
RECRUITING

Wilson, North Carolina, 27896, United States
Florida Cancer Specialists - East
RECRUITING

West Palm Beach, Florida, 33401, United States
Florida Cancer Specialists - North
RECRUITING

Orange City, Florida, 32763, United States
Florida Cancer Specialists - South
RECRUITING

Fort Myers, Florida, 33901, United States
Illinois Cancer Care
RECRUITING

Peoria, Illinois, 61615, United States
Illinois Cancer Specialists
RECRUITING

Arlington Heights, Illinois, 60005, United States
Indiana University Simon Cancer Center
RECRUITING

Indianapolis, Indiana, 46202, United States
Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center
RECRUITING

Columbus, Ohio, 43219, United States
Minnesota Oncology Hematology
RECRUITING

Maple Grove, Minnesota, 55369, United States
Missouri Cancer Associates
RECRUITING

Columbia, Missouri, 65201, United States
Ocala Oncology Center
RECRUITING

Ocala, Florida, 34474, United States
Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)
RECRUITING

Eugene, Oregon, 97401, United States
Oncology Hematology Care
RECRUITING

Cincinnati, Ohio, 45242, United States
Piedmont Healthcare - Atlanta
RECRUITING

Atlanta, Georgia, 30309, United States
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Sansum Clinic
RECRUITING

Santa Barbara, California, 93105, United States
Southern Cancer Center
RECRUITING

Daphne, Alabama, 36526, United States
Tennessee Cancer Specialists
RECRUITING

Knoxville, Tennessee, 37909, United States
Texas Oncology - DFW
RECRUITING

Dallas, Texas, 75246, United States
Texas Oncology - Gulf Coast
RECRUITING

Beaumont, Texas, 77702, United States
Texas Oncology - Northeast Texas
RECRUITING

Denison, Texas, 75020, United States
Texas Oncology - San Antonio
RECRUITING

San Antonio, Texas, 78240, United States
Texas Oncology - West Texas
RECRUITING

Amarillo, Texas, 79124, United States
Texas Oncology- Austin
RECRUITING

Austin, Texas, 78705, United States
The Ohio State University - Arthur James Cancer Hospital & Solove Research Institute
RECRUITING

Columbus, Ohio, 43210, United States
University of Miami - Sylvester Cancer Center
ACTIVE_NOT_RECRUITING

Miami, Florida, 33136, United States
Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States
White Plains Hospital Physician Associates
RECRUITING

White Plains, New York, 10601, United States

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