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RecruitingLast updated: 10 July 2026

MountainTAP-29: Adding the targeted drug navlimetostat to standard treatments for people with metastatic (stage IV or recurrent) non-small cell lung cancerA Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

MountainTAP-29

Clinical summary

Summary

This study is testing whether adding a targeted drug called navlimetostat (also known as BMS-986504) to standard treatment improves outcomes for people with advanced lung cancer.

All participants have non-small cell lung cancer (NSCLC) that has spread (stage IV metastatic or recurrent) and has a specific genetic change called MTAP deletion. Participants should not have received prior drug treatment for their metastatic disease, but treatment at an earlier stage is permitted.

Participants will receive:

  • standard treatment with immunotherapy (pembolizumab) and chemotherapy, and
  • either the new drug (navlimetostat) or a placebo (inactive treatment).

The study aims to find out if the new combination helps people live longer or keeps their cancer under control for longer compared to standard treatment alone.

Conditions

This trial is treating people with metastatic non-small cell lung cancer

Eligibility

Inclusion

  • Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
  • Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion

  • Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
  • Participants must not have symptomatic brain metastases or spinal cord compression.
  • Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).

Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.

  • Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07063745 *
  • 2025-521511-40 *
  • CA240-0029; U1111-1319-8383; CA2400029

Trial sponsor

Bristol-Myers Squibb

Scientific Title

A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

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