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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 416 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 65 sites (Birmingham, Alabama and 64 other locations) |
| Status | Recruiting |
| Started | February 4, 2025 |
| Main results expected | February 26, 2031 |
| Study ends | February 26, 2031 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT06618287 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
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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
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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
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.