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BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab nel carcinoma polmonare a piccole cellule in stadio limitato (TIGOS-LS) (TIGOS-LS)

16 settembre 2026 aggiornato da: SCRI Development Innovations, LLC

Uno studio randomizzato in aperto su BMS-986489 (combinazione a dose fissa di Atigotatug + Nivolumab) rispetto a Durvalumab come terapia di consolidamento dopo chemioradioterapia nel carcinoma polmonare a piccole cellule in stadio limitato (TIGOS-LS)

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

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in participants with limited-stage (LS)-small-cell lung cancer (SCLC). Participants will receive concurrent chemotherapy and radiotherapy according to standard guidelines for treatment of LS-SCLC without progressive disease prior to randomization. Eligible participants will be randomly assigned to receive either BMS-986489 (atigotatug + nivolumab as a fixed-dose combination; Arm A) or durvalumab (Arm B) as consolidation therapy. Atigotatug is a first-in-class, fully human IgG1 antibody being developed for the treatment of SCLC. Atigotatug specifically binds to fuc-GM1 on the tumor cell. Nivolumab is a monoclonal anti-PD-1 antibody. Combining atigotatug with another immunotherapy may provide enhanced antitumor effects.

Tipo di studio

Interventistico

Iscrizione (Stimato)

250

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Daphne, Alabama, Stati Uniti, 36526
        • Southern Cancer Center
    • California
      • Santa Barbara, California, Stati Uniti, 93105
        • Sansum Clinic
    • Florida
      • Fort Myers, Florida, Stati Uniti, 33901
        • Florida Cancer Specialists - South
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami - Sylvester Cancer Center
      • Ocala, Florida, Stati Uniti, 34474
        • Ocala Oncology Center
      • Orange City, Florida, Stati Uniti, 32763
        • Florida Cancer Specialists - North
      • Palm Bay, Florida, Stati Uniti, 32901
        • Cancer Care Centers of Brevard
      • West Palm Beach, Florida, Stati Uniti, 33401
        • Florida Cancer Specialists - East
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
        • Piedmont Healthcare - Atlanta
    • Illinois
      • Arlington Heights, Illinois, Stati Uniti, 60005
        • Illinois Cancer Specialists
      • Peoria, Illinois, Stati Uniti, 61615
        • Illinois Cancer Care
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University Simon Cancer Center
    • Kentucky
      • Corbin, Kentucky, Stati Uniti, 40701
        • Baptist Health - Corbin
      • Lexington, Kentucky, Stati Uniti, 40503
        • Baptist Health - Lexington
      • Louisville, Kentucky, Stati Uniti, 40207
        • Baptist Health - Louisville
    • Minnesota
      • Maple Grove, Minnesota, Stati Uniti, 55369
        • Minnesota Oncology Hematology
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65201
        • Missouri Cancer Associates
    • New York
      • White Plains, New York, Stati Uniti, 10601
        • White Plains Hospital Physician Associates
    • North Carolina
      • Wilson, North Carolina, Stati Uniti, 27896
        • Carolina Cancer Research Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45242
        • Oncology Hematology Care
      • Columbus, Ohio, Stati Uniti, 43210
        • The Ohio State University - Arthur James Cancer Hospital & Solove Research Institute
      • Columbus, Ohio, Stati Uniti, 43219
        • Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center
    • Oregon
      • Eugene, Oregon, Stati Uniti, 97401
        • Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37909
        • Tennessee Cancer Specialists
      • Nashville, Tennessee, Stati Uniti, 37203
        • SCRI Oncology Partners
    • Texas
      • Amarillo, Texas, Stati Uniti, 79124
        • Texas Oncology - West Texas
      • Austin, Texas, Stati Uniti, 78705
        • Texas Oncology- Austin
      • Beaumont, Texas, Stati Uniti, 77702
        • Texas Oncology - Gulf Coast
      • Dallas, Texas, Stati Uniti, 75246
        • Texas Oncology - DFW
      • Denison, Texas, Stati Uniti, 75020
        • Texas Oncology - Northeast Texas
      • San Antonio, Texas, Stati Uniti, 78240
        • Texas Oncology - San Antonio
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, Stati Uniti, 23502
        • Virginia Oncology Associates
      • Salem, Virginia, Stati Uniti, 24153
        • Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Comparatore attivo: 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.
Droga: Durvalumab

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Lasso di tempo: 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

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).
Lasso di tempo: 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.

Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of an event, defined as the first documented radiological progression or death due to any cause.
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).
Lasso di tempo: 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.

Objective Response Rate (ORR) is defined as the proportion of participants with BOR of CR or PR according to RECIST v1.1.
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).
Lasso di tempo: 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.

Clinical Benefit Rate (CBR) is defined as the proportion of participants with BOR of CR or PR, or participants with SD lasting at least 180 days (i.e., ≥6 months) according to RECIST v1.1.
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).
Lasso di tempo: 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.

Disease Control Rate (DCR) is defined as the proportion of participants with BOR of CR, PR, or SD according to RECIST v1.1
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).
Lasso di tempo: 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.

Duration of Response (DoR) is defined as the duration from the first documented response (Complete Response (CR), Partial Response (PR), or Stable Disease (SD), according to RECIST v1.1) to the date of first documented disease progression or death.
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 Time to Progression (TtP).
Lasso di tempo: 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.

Time to Progression (TtP) is defined as the time from the date of randomization to the date of first documented disease progression, according to RECIST v1.1.
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 time to development of central nervous system (CNS) metastasis.
Lasso di tempo: 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.

Time to development of central nervous system (CNS) metastasis is defined as the time from the date of randomization to the date of first documented CNS metastasis.
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 number of participants with adverse events following administration of BMS-986489.
Lasso di tempo: From Cycle 1 Day 1 to 100 days after the last dose of BMS-986489. Each cycle is 28 days.

Adverse Events to be evaluated per CTCAE v5.0 criteria from first dose of BMS-986489 to 100 days after the last dose of BMS-986489.
From Cycle 1 Day 1 to 100 days after the last dose of BMS-986489. Each cycle is 28 days.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SCRI Development Innovations, LLC

Collaboratori

Bristol-Myers Squibb

Investigatori

  • Cattedra di studio: Melissa Johnson, MD, SCRI Development Innovations, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 marzo 2025

Completamento primario (Stimato)

1 maggio 2032

Completamento dello studio (Stimato)

1 settembre 2032

Date di iscrizione allo studio

Primo inviato

8 gennaio 2025

Primo inviato che soddisfa i criteri di controllo qualità

8 gennaio 2025

Primo Inserito (Effettivo)

14 gennaio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LUN 567

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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