Clinical trial Recruiting at 47 sites Phase1; Phase2 Interventional Ages 18 and up

Evaluating a new drug combination for advanced lung cancer

Official title: A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Run by Bristol-Myers Squibb · NCT06618287 · Data updated 2026-11-12

This study is testing a new combination of drugs for adults with advanced lung cancer to see if it is safe and effective when used with existing treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment416 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations65 sites (Birmingham, Alabama and 64 other locations)
StatusRecruiting
StartedFebruary 4, 2025
Main results expectedFebruary 26, 2031
Study endsFebruary 26, 2031
Registry record updatedSeptember 23, 2026
Trial IDNCT06618287 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults with advanced non-small cell lung cancer who have measurable lesions and a good performance status.

Probably not a fit

Patients with mixed small cell and non-small cell lung cancer or untreated symptomatic central nervous system metastases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, drug levels, and preliminary efficacy of a combination of BMS-986507 with other treatments in adults with advanced solid tumors, specifically targeting lung cancer. Participants will receive the investigational drug alongside established therapies like Osimertinib and Pembrolizumab. The study will include patients with measurable lesions and will monitor their response to the treatment over time. The goal is to gather data that could inform future treatment options for this patient population.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced lung cancer.

How similar studies have gone: Other studies have shown promise with similar drug combinations in treating advanced lung cancer, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria

* Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participants must have a life expectancy of at least 3 months at the time of the first dose.
* Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed
* Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.
* Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.
* Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen.
* Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.

Exclusion Criteria

* Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
* Participants with known mutations in EGFR will be excluded (Group A,B and E).
* Participants must not have a history of serious recurrent infections.
* Participants must not have a history of severe heart disease.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center
    Miami, Florida, United States
    Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Recruiting
  • Providence Portland Medical Center
    Portland, Oregon, United States
    Recruiting
  • Providence St. Vincent Medical Center
    Portland, Oregon, United States
    Recruiting
Show 44 more locations
  • University of Tennessee Medical Center
    Knoxville, Tennessee, United States
    Recruiting
  • NEXT Oncology - Irving
    Irving, Texas, United States
    Recruiting
  • Swedish Medical Center
    Seattle, Washington, United States
    Recruiting
  • Liverpool Hospital
    Liverpool, New South Wales, Australia
    Recruiting
  • Princess Alexandra Hospital
    Woolloongabba, Queensland, Australia
    Recruiting
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria, Australia
    Recruiting
  • St. John of God Subiaco Hospital
    Subiaco, Western Australia, Australia
    Recruiting
  • Cross Cancer Institute
    Edmonton, Alberta, Canada
    Recruiting
  • The Ottawa Hospital - General Campus
    Ottawa, Ontario, Canada
    Recruiting
  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec, Canada
    Recruiting
  • Jewish General Hospital
    Montreal, Quebec, Canada
    Recruiting
  • Oncocentro Valdivia
    Valdivia, Los Ríos Region, Chile
    Recruiting
  • Falp
    Santiago, Santiago Metropolitan, Chile
    Recruiting
  • Pontificia Universidad Catolica de Chile
    Santiago, Santiago Metropolitan, Chile
    Recruiting
  • Bradfordhill
    Santiago, Santiago Metropolitan, Chile
    Recruiting
  • Oncocentro Apys
    Viña del Mar, Valparaiso, Chile
    Recruiting
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
    Bordeaux, Aquitaine, France
    Recruiting
  • Centre Leon Berard
    Lyon, Auvergne-Rhône-Alpes, France
    Recruiting
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
    Marseille, Bouches-du-Rhône, France
    Recruiting
  • Hôpital Arnaud de Villeneuve - CHU Montpellier
    Montpellier, Hérault, France
    Recruiting
  • Gustave Roussy
    Villejuif, Val-de-Marne, France
    Recruiting
  • Institut Curie
    Paris, France
    Recruiting
  • Hôpital Tenon
    Paris, France
    Recruiting
  • Cro-Irccs
    Aviano, Friuli Venezia Giulia, Italy
    Recruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milan, Lombardy, Italy
    Recruiting
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
    Candiolo, Torino, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Careggi
    Florence, Tuscany, Italy
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
    Roma, Italy
    Recruiting
  • Leids Universitair Medisch Centrum
    Leiden, South Holland, Netherlands
    Recruiting
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
    Amsterdam, Netherlands
    Recruiting
  • CHUS - Hospital Clinico Universitario
    Santiago de Compostela, A Coruña [La Coruña], Spain
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, Barcelona [Barcelona], Spain
    Recruiting
  • Institut Català d'Oncologia - L'Hospitalet
    Hospitalet, Barcelona [Barcelona], Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Madrid, Comunidad de, Spain
    Recruiting
  • Hospital Universitario Puerta de Hierro Majadahonda
    Majadahonda, Madrid, Comunidad de, Spain
    Recruiting
  • Hospital Universitario Fundación Jiménez Díaz
    Madrid, Spain
    Recruiting
  • Hospital Universitario HM Sanchinarro
    Madrid, Spain
    Recruiting
  • H.R.U Málaga - Hospital General
    Málaga, Spain
    Recruiting
  • Hospital Universitari i Politecnic La Fe
    Valencia, Spain
    Recruiting
  • Royal Free Hospital
    London, England, United Kingdom
    Recruiting
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, West Midlands, United Kingdom
    Recruiting
  • Local Institution - 0065
    Iowa City, Iowa, United States
    Not yet recruiting
  • Local Institution - 0140
    St Louis, Missouri, United States
    Not yet recruiting
  • Local Institution - 0102
    Columbus, Ohio, United States
    Not yet recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.