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)

Korábbi kezelés

• Prior treatment with a PRMT5 or MAT2A inhibitor.

Más betegség

• 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.
• Known severe hypersensitivity to study treatment and/or any of its excipients.

Laborértékek

• For combination arms
  • 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.

Egyéb

• Active brain metastases or carcinomatous meningitis.
• Other protocol-defined inclusion/exclusion criteria apply.

• 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
  • Participants must have documented evidence of EGFR status.
  • Participants with EGFR mutant or wild type NSCLC are allowed.