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RecruitingPhase 2

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)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe navlimetostat (BMS-986504) is and how well it works, alone or with izalontamab brengitecan. It is for adults with advanced or spreading non-small cell lung cancer that has worsened after past treatment and has lost both copies of the MTAP gene or has MTAP loss.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by a tissue test, with both copies of the MTAP gene missing. Be willing to provide stored or new tumor samples to confirm MTAP status.
  • Have advanced cancer or cancer that has spread, cannot be treated with the aim of a cure, and has worsened after past treatment.
  • Have at least one tumor that can be measured using study rules.
  • Have scans showing the cancer worsened during or after the most recent treatment.
  • Be fully active or able to walk and do light work despite limits on hard physical activity.
  • Be at least 18 years old, or the local legal age to consent, when signing the consent form.
  • Be able to swallow tablets whole, without chewing or crushing them.
  • For the two-drug groups, have documented EGFR gene test results. People with or without an EGFR gene change may join.

Who can't join

  • Have active cancer spread to the brain or cancer in the tissue covering the brain and spinal cord.
  • Have a history of stomach or bowel disease, or other digestive problems, that could affect how the body takes in the study drug or prevent swallowing pills.
  • Have had a drug that blocks PRMT5 or MAT2A.
  • Have a known severe allergy to a study drug or any of its ingredients.
  • For the two-drug groups, have had izalontamab brengitecan or certain antibody treatments, including antibodies linked to cancer drugs, that target EGFR or HER3 or carry a drug that blocks topoisomerase 1. Past amivantamab treatment is allowed.
  • Other study rules may also affect who can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (10)

AK

MA

MI

MO

NY

OH

OR

WA

WI