Recruiting
Phase 2

Atigotatug & Nivolumab vs. Durvalumab

Sponsor:

SCRI Development Innovations, LLC

Code:

NCT06773910

Conditions

Limited Stage Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986489

Durvalumab

Study Details

Brief summary:

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants.

The main goals of this study are to:

  • Evaluate the efficacy of BMS-986489 vs durvalumab
  • Evaluate the safety profile of BMS-986489

Conditions

Limited Stage Small Cell Lung Cancer

Study ID

NCT06773910

Start date

Mar 11, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2032

Anticipated

Primary completion date

May, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BMS-986489 (atigotatug + nivolumab)

Participants will receive a fixed dose of BMS-986489 (atigotatug + nivolumab) intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.

active comparator: Durvalumab

Participants will receive standard of care Durvalumab intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.

Interventions

BMS-986489

BMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.

Durvalumab

Durvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.

Primary outcome measure

  • Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS). [ Time Frame: From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and ]

Central Contacts and Locations

Central contacts

Sarah Cannon Development Innovations, LLC

1-844-710-6157SCRI.InnovationsMedical@scri.com

Locations

Southern Cancer Center

Recruiting

Daphne, Alabama, United States, 36526

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Florida Cancer Specialists - South

Recruiting

Fort Myers, Florida, United States, 33901

Ocala Oncology Center

Recruiting

Ocala, Florida, United States, 34474

Florida Cancer Specialists - North

Recruiting

Orange City, Florida, United States, 32763

Cancer Care Centers of Brevard

Recruiting

Palm Bay, Florida, United States, 32901

Florida Cancer Specialists - East

Recruiting

West Palm Beach, Florida, United States, 33401

Piedmont Healthcare - Atlanta

Recruiting

Atlanta, Georgia, United States, 30309

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

Indiana University Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Baptist Health - Corbin

Recruiting

Corbin, Kentucky, United States, 40701

Baptist Health - Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Baptist Health - Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Minnesota Oncology Hematology

Recruiting

Maple Grove, Minnesota, United States, 55369

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

White Plains Hospital Physician Associates

Recruiting

White Plains, New York, United States, 10601

Carolina Cancer Research Center

Recruiting

Wilson, North Carolina, United States, 27896

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

The Ohio State University - Arthur James Cancer Hospital & Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210

Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center

Recruiting

Columbus, Ohio, United States, 43219

Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)

Recruiting

Eugene, Oregon, United States, 97401

Tennessee Cancer Specialists

Recruiting

Knoxville, Tennessee, United States, 37909

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - West Texas

Recruiting

Amarillo, Texas, United States, 79124

Texas Oncology- Austin

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Gulf Coast

Recruiting

Beaumont, Texas, United States, 77702

Texas Oncology - DFW

Recruiting

Dallas, Texas, United States, 75246

Texas Oncology - Northeast Texas

Recruiting

Denison, Texas, United States, 75020

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)

Recruiting

Salem, Virginia, United States, 24153

More Information

Sponsor

SCRI Development Innovations, LLC

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • limited stage small cell lung cancer
  • limited stage small cell lung carcinoma
  • LS-SCLC
  • Limited-stage SCLC
  • Nivolumab
  • Opdivo
  • fucosyl-monosialoganglioside-1
  • fuc-GM1
  • programmed cell death protein 1
  • PD-1 inhibitor
  • anti-PD-1 antibody
  • Durvalumab
  • Imfinzi
  • PD-L1 inhibitor
  • Anti-PD-L1 antibody
  • Limited-stage (LS)-small-cell lung cancer (SCLC)
  • BMS-986489

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SCRI Development Innovations, LLC on 2026-08-17.