A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9)

September 17, 2026 updated by: Bristol-Myers Squibb

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy and in Combination With Izalontamab Brengitecan in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss After Progression on Prior Therapies

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy or in combination with Izalontamab Brengitecan in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion or MTAP loss after progression on prior therapies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • GenesisCare - Campbelltown
        • Contact:
          • Jessica Smith, Site 0057
          • Phone Number: +61 2 4632 5500
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Chris O'Brien Lifehouse
        • Contact:
          • Steven Kao, Site 0059
          • Phone Number: +61 2 85140594
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Wen Xu, Site 0058
          • Phone Number: (+61) 731762111
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Completed
        • Local Institution - 0097
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 101149
        • Recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Contact:
          • Zhe Liu, Site 0039
          • Phone Number: 010-8909303
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Feng Ye, Site 0055
          • Phone Number: 8613860458889
    • Guangxi
      • Nanning, Guangxi, China, 530201
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
          • Wenhua Zhao, Site 0050
          • Phone Number: 13878873120
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Longhua Sun, Site 0043
          • Phone Number: 8613698091288
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Ligang Xing, Site 0054
          • Phone Number: 86-15553181309
      • Linyi, Shandong, China, 276001
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Jianhua Shi, Site 0044
          • Phone Number: +8615963998868
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Contact:
          • Enguo Chen, Site 0049
          • Phone Number: 13588706779
      • Linhai, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Dongqing LV, Site 0053
          • Phone Number: 13867622009
  • France
      • Paris, France, 75248
        • Recruiting
        • Institut Curie
        • Contact:
          • nicolas girard, Site 0107
          • Phone Number: +33624456290
      • Paris, France, 75970
        • Recruiting
        • Hôpital Tenon
        • Contact:
          • Jacques Cadranel, Site 0027
          • Phone Number: 33156016531
      • Paris, France, 75014
        • Recruiting
        • Hopitaux Universitaires Paris Centre-Hopital Cochin
        • Contact:
          • Marie Wislez, Site 0013
          • Phone Number: 33158413091
    • Isère
      • La Tronche, Isère, France, 38700
        • Recruiting
        • CHU Grenoble Alpes
        • Contact:
          • Denis Moro-Sibilot, Site 0015
          • Phone Number: 33476765467
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44800
        • Recruiting
        • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
        • Contact:
          • Elvire Pons-Tostivint, Site 0012
          • Phone Number: +33676133810
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
        • Contact:
          • Bertrand Mennecier, Site 0095
          • Phone Number: 33383154653
    • Rhône
      • Bron, Rhône, France, 69677
        • Recruiting
        • Hospices Civils de Lyon - Hopital Louis Pradel
        • Contact:
          • Michael Duruisseaux, Site 0041
          • Phone Number: 33427857700
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75014
        • Recruiting
        • Groupe hospitalier Paris saint Joseph
        • Contact:
          • Carole Helissey-Danis, Site 0096
          • Phone Number: 33330143985319
  • Germany
      • Cologne, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln
        • Contact:
          • Juergen Wolf, Site 0067
          • Phone Number: +4922147889050
      • Würzburg, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Elisabeth Goebeler, Site 0065
          • Phone Number: 4993120140155
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Recruiting
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
        • Contact:
          • Diego Kauffmann-Guerrero, Site 0068
          • Phone Number: 4989440052590
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt Goethe-Universität
        • Contact:
          • Fabian Acker, Site 0070
          • Phone Number: 0000
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Dölau
        • Contact:
          • Miriam Moeller, Site 0066
          • Phone Number: 00493455591440
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Francesco Gelsomino, Site 0024
          • Phone Number: +390512142203
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Claudia Proto, Site 0019
          • Phone Number: 390223903829
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
        • Contact:
          • Alessandro Morabito, Site 0020
          • Phone Number: 390817770291
      • Naples, Campania, Italy, 80131
        • Recruiting
        • AOU della Campania Luigi Vanvitelli
        • Contact:
          • Carminia Maria Della Corte, Site 0026
          • Phone Number: 3929160541
    • Lombardy
      • Monza, Lombardy, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Diego Cortinovis, Site 0025
          • Phone Number: 390392333683
    • Milano
      • Milan, Milano, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Giulio Cerea, Site 0022
          • Phone Number: 390264442291
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
          • Giulia Pasello, Site 0023
          • Phone Number: 39498215620
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • Hibiki Udagawa, Site 0092
          • Phone Number: 81471331111
    • Miyagi
      • Sendai, Miyagi, Japan, 9810914
        • Recruiting
        • Sendai Kousei Hospital
        • Contact:
          • Shunichi Sugawara, Site 0094
          • Phone Number: 81227288000
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Contact:
          • Takayasu Kurata, Site 0093
          • Phone Number: 81728042503
  • Poland
      • Prabuty, Poland, 82-550
        • Recruiting
        • Szpital Specjalistyczny w Prabutach Spolka z o.o.
        • Contact:
          • Anna Lowczak, Site 0064
          • Phone Number: +48503022396
    • Masovian Voivodeship
      • Wieliszew, Masovian Voivodeship, Poland, 05-135
        • Recruiting
        • Mazowiecki Szpital Onkologiczny
        • Contact:
          • Renata Biernacka, Site 0060
          • Phone Number: 509120229
  • Romania
      • Bucharest, Romania, 020335
        • Recruiting
        • Centrul de Diagnostic si Tratament Provita
        • Contact:
          • Mircea Dediu, Site 0040
          • Phone Number: 0040744432443
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj
        • Contact:
          • Tudor Ciuleanu, Site 0034
          • Phone Number: 40745646368
      • Iași, Romania, 700106
        • Recruiting
        • S.C. Centrul de Oncologie Euroclinic S.R.L.
        • Contact:
          • Constantin Volovat, Site 0030
          • Phone Number: 40746110096
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie
        • Contact:
          • Dana Clement, Site 0032
          • Phone Number: 40744692062
    • Bucharest
      • Bucharest, Bucharest, Romania, 022338
        • Recruiting
        • Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
        • Contact:
          • Aurelia Alexandru, Site 0029
          • Phone Number: 40723289606
    • Cluj
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL
        • Contact:
          • Andrei Ungureanu, Site 0036
          • Phone Number: 40742206212
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"
        • Contact:
          • Michael Schenker, Site 0031
          • Phone Number: 40727774974
  • Spain
      • Málaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General
        • Contact:
          • Manuel Cobo-Dols, Site 0075
          • Phone Number: 00349422033350000
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • Reyes Bernabe Caro, Site 0089
          • Phone Number: 34955015273
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Oscar Juan Vidal, Site 0072
          • Phone Number: 34961245877
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Enriqueta Felip Font, Site 0074
          • Phone Number: 34932746077
      • Hospitalet, Barcelona [Barcelona], Spain, 08907
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet
        • Contact:
          • Ernest Nadal Alforja, Site 0073
          • Phone Number: 34932607283
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Maria Eugenia Olmedo Garcia, Site 0077
          • Phone Number: 34913368263
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Luis Paz-Ares Rodriguez, Site 0071
          • Phone Number: +34913908546
      • Madrid, Madrid, Comunidad de, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Javier de Castro Carpeno, Site 0076
          • Phone Number: 34917277516
  • Sweden
    • Stockholms Län [se-01]
      • Solna, Stockholms Län [se-01], Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
        • Contact:
          • Luigi DePetris, Site 0002
          • Phone Number: 45 08-123 79517
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
          • Andreas Hallqvist, Site 0003
          • Phone Number: +46735-985411
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital
        • Contact:
          • Alastair Greystoke, Site 0004
          • Phone Number: +44 (0)191 213 8450
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital Birmingham
        • Contact:
          • Gary Middleton, Site 0069
          • Phone Number: +44 121 3718783
    • London, City of
      • London, London, City of, United Kingdom, w1g 6ad
        • Recruiting
        • Sarah Cannon Research Institute UK
        • Contact:
          • Elisa Fontana, Site 0008
          • Phone Number: +44 (0) 203 219 5234
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Completed
        • Local Institution - 0088
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Pasi Janne, Site 0090
          • Phone Number: 617-632-6036
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
          • Hirva Mamdani, Site 0100
          • Phone Number: 909-525-0093
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Anjali Rohatgi, Site 0104
          • Phone Number: 314-747-1171
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Kathryn Arbour, Site 0018
          • Phone Number: 646-608-3792
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
        • Contact:
          • Nashat Gabrail, Site 0091
          • Phone Number: 330-417-8231
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
          • Jeremy Cetnar, Site 0103
          • Phone Number: 503-494-3840
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
          • Rachel Sanborn, Site 0098
          • Phone Number: 503-215-5696
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchison Cancer Center
        • Contact:
          • Lei Deng, Site 0078
          • Phone Number: 206-606-4801
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Jonathan Thompson, Site 0084
          • Phone Number: 414-805-4600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
  • Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
  • At least 1 measurable lesion as per RECIST v1.1.
  • Documented radiographic disease progression on or after the most recent line of treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
  • Capability to swallow tablets intact (without chewing or crushing).

  • For combination arms

    1. Participants must have documented evidence of EGFR status.
    2. Participants with EGFR mutant or wild type NSCLC are allowed.

Exclusion Criteria

  • Active brain metastases or carcinomatous meningitis.
  • History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Prior treatment with a PRMT5 or MAT2A inhibitor.
  • Known severe hypersensitivity to study treatment and/or any of its excipients.

  • For combination arms

    a. Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab.

  • Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: BMS-986504 Dose 1
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Arm B: BMS-986504 Dose 2
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Arm C: BMS-986504 Dose 1 + Izalontamab Brengitecan
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Izalontamab Brengitecan
Specified dose on specified days
Other Names:
  • BMS-986507
  • Iza-bren
  • BL-BO1D1
Experimental: Arm D: BMS-986504 Dose 2 + Izalontamab Brengitecan
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Izalontamab Brengitecan
Specified dose on specified days
Other Names:
  • BMS-986507
  • Iza-bren
  • BL-BO1D1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
OR is defined as confirmed complete response (CR) or partial response (PR)
Up to 3 years after the last participant's last dose of study treatment
Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with adverse events (AE)
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with Serious AEs (SAEs)
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with treatment related AEs
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with treatment related SAEs
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with AEs leading to study treatment discontinuation
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with AEs leading to death
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment
Number of participants with laboratory abnormalities
Time Frame: Up to 28 days after the last dose of study treatment
Arm C and Arm D
Up to 28 days after the last dose of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants who achieve disease control (DC) as assessed by RECIST v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
DC is defined as Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)
Up to 3 years after the last participant's last dose of study treatment
Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
CB is defined as BOR of confirmed CR, confirmed PR, or SD for at least 6 months after start of treatment
Up to 3 years after the last participant's last dose of study treatment
Progression-free survival (PFS) as assessed by RECIST v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
PFS is defined as the time between randomization and the date of disease progression or death from any cause (whichever occurs first)
Up to 3 years after the last participant's last dose of study treatment
Number of participants with adverse events (AE)
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment
Number of participants with Serious AEs (SAEs)
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment
Number of participants with AEs leading to dose interruption, reduction, or discontinuation
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment
Number of deaths
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment
Overall Survival (OS)
Time Frame: Up to 3 years after the last participant's last dose of study treatment
OS is defined as the time between the randomization/the start of treatment to death due to any cause
Up to 3 years after the last participant's last dose of study treatment
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment
Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
Up to 3 years after the last participant's last dose of study treatment
Duration of response (DOR) as assessed by RECIST v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
DOR is defined as the time between the date of the first documentation of objective tumor response (confirmed CR or PR) and the date of disease progression or to death from any cause (whichever occurs first)
Up to 3 years after the last participant's last dose of study treatment
Time to objective response (TTOR) as assessed by RECIST v1.1
Time Frame: Up to 3 years after the last participant's last dose of study treatment
TTOR is defined as the time between randomization to the date of the first documentation of objective tumor response (confirmed CR or PR)
Up to 3 years after the last participant's last dose of study treatment
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core Function Global Health Status score
Time Frame: Up to 28 days after the last dose of study treatment
Up to 28 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA240-0009
  • 2024-519814-29 (Other Identifier: EU CTR)
  • U1111-1315-9473 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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