BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)

NCT06773910 | Recruiting Phase 2 FDA Drug

• 1 other identifier: LUN 567
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 33

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

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).

  Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.

  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

Secondary Outcomes (8)

• Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).

  Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

• Evaluate the efficacy of BMS-986489 vs durvalumab Objective Response Rate (ORR).

  Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

• Evaluate the efficacy of BMS-986489 vs durvalumab by Clinical Benefit Rate (CBR).

  Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

• Evaluate the efficacy of BMS-986489 vs durvalumab by Disease Control Rate (DCR).

  Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

• Evaluate the efficacy of BMS-986489 vs durvalumab by Duration of Response (DoR).

  Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Study Arms (2)

BMS-986489 (atigotatug + nivolumab)

EXPERIMENTAL

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.

Drug: BMS-986489

Durvalumab

ACTIVE COMPARATOR

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.

Drug: Durvalumab

Interventions

BMS-986489 DRUG

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.

BMS-986489 (atigotatug + nivolumab)

Durvalumab DRUG

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

Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bristol-Myers Squibb: collaborator

Study Sites (33)

Southern Cancer Center

Daphne, Alabama, 36526, United States

RECRUITING

Sansum Clinic

Santa Barbara, California, 93105, United States

RECRUITING

Florida Cancer Specialists - South

Fort Myers, Florida, 33901, United States

RECRUITING

University of Miami - Sylvester Cancer Center

Miami, Florida, 33136, United States

ACTIVE NOT RECRUITING

Ocala Oncology Center

Ocala, Florida, 34474, United States

RECRUITING

Florida Cancer Specialists - North

Orange City, Florida, 32763, United States

RECRUITING

Cancer Care Centers of Brevard

Palm Bay, Florida, 32901, United States

RECRUITING

Florida Cancer Specialists - East

West Palm Beach, Florida, 33401, United States

RECRUITING

Piedmont Healthcare - Atlanta

Atlanta, Georgia, 30309, United States

RECRUITING

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

RECRUITING

Illinois Cancer Care

Peoria, Illinois, 61615, United States

RECRUITING

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Baptist Health - Corbin

Corbin, Kentucky, 40701, United States

RECRUITING

Baptist Health - Lexington

Lexington, Kentucky, 40503, United States

RECRUITING

Baptist Health - Louisville

Louisville, Kentucky, 40207, United States

RECRUITING

Minnesota Oncology Hematology

Maple Grove, Minnesota, 55369, United States

RECRUITING

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

RECRUITING

White Plains Hospital Physician Associates

White Plains, New York, 10601, United States

RECRUITING

Carolina Cancer Research Center

Wilson, North Carolina, 27896, United States

RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

RECRUITING

Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center

Columbus, Ohio, 43219, United States

RECRUITING

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

Eugene, Oregon, 97401, United States

RECRUITING

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - West Texas

Amarillo, Texas, 79124, United States

RECRUITING

Texas Oncology- Austin

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702, United States

RECRUITING

Texas Oncology - DFW

Dallas, Texas, 75246, United States

RECRUITING

Texas Oncology - Northeast Texas

Denison, Texas, 75020, United States

RECRUITING

Texas Oncology - San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

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

Salem, Virginia, 24153, United States

RECRUITING

MeSH Terms

Interventions

durvalumab

Study Officials

• Melissa Johnson, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Central Study Contacts

Sarah Cannon Development Innovations, LLC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)