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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)
ClinicalTrials.gov ID: NCT06855771
What this study is testing
What is BMS-986504?
BMS-986504 is an investigational medicine, being studied as a potential treatment for carcinoma, non-small-cell lung.
Also referred to as MRTX1719, Navlimetostat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples...
- Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American...
- 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.
You likely can't join if
- Active brain metastases or carcinomatous meningitis.
- History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter...
- Prior treatment with a PRMT5 or MAT2A inhibitor.
- Known severe hypersensitivity to study treatment and/or any of its excipients.
- Other protocol-defined inclusion/exclusion criteria apply.
See the full eligibility 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).
- 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...
- Prior treatment with a PRMT5 or MAT2A inhibitor.
- Known severe hypersensitivity to study treatment and/or any of its excipients.
- Other protocol-defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Boise, Idaho, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Shirley, New York, United States
- Canton, Ohio, United States
- Portland, Oregon, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Campbelltown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Nanning, Guangxi, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Boise, Idaho, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; St Louis, Missouri, United States; New York, New York, United States and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.