RecruitingPhase 2 / Phase 3

A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

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

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 whether adding navlimetostat (BMS-986504) to pembrolizumab and chemotherapy works better than adding a placebo (a treatment with no active drug). It is for people starting treatment for non-small cell lung cancer that has spread and has both copies of the MTAP gene missing or has MTAP loss.

The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

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 that has spread (stage IV or cancer that has come back), with no prior whole-body cancer treatment for the spread.
  • Have a diagnosis confirmed by a tissue test, with both copies of the MTAP gene missing or MTAP loss.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have at least one cancer spot that can be measured.

Who can't join

  • For people with the nonsquamous type of lung cancer: have a gene change with an available standard treatment used as the first treatment.
  • Have cancer that has spread to the brain and causes symptoms, or pressure on the spinal cord.
  • Have already had whole-body treatment for lung cancer that has spread, such as chemotherapy, immune therapy, or targeted therapy. One cycle of standard treatment may be allowed before study group assignment if treatment is needed right away.
  • Have a known or suspected problem with the stomach or intestines that could prevent absorbing medicine or swallowing it without chewing or crushing.
  • Other study rules also apply.

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

Official eligibility criteria

Inclusion Criteria * 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 Criteria * 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.

Study sites (44)

AK

AR

AZ

CA

DE

FL

ID

  • St. Luke's Cancer Institute: Boise · Boise, ID 83712Sri Harsha Tella, Site 0124 · Study contactMore trials in Boise

IL

KY

MA

ME

MI

MN

NC

NE

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists · Omaha, NE 68130Geetha Palaniappan, Site 0160 · Study contact · 402-593-3141More trials in Omaha

NH

NY

OH

OR

PA

SC

TN

TX

UT

VA

WA