Trial NCT06855771
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)
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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.Brain metastases
* 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.
Restrictions found (2)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County