Navlimetostat + Pumitamig

Primary Objectives: Phase I: To evaluate the safety of navlimetostat in combination with pumitamig. Phase II: To evaluate the efficacy of navlimetostat in combination with pumitamig.

Secondary Objectives: * To evaluate toxicity and tolerability of navlimetostat in combination with pumitamig. * To evaluate efficacy outcomes including disease control rate, progression-free survival, overall survival, and duration of response. * To compare the efficacy of the combination in patients with prior ICI exposure and those without (treated with targeted therapy and/or chemotherapy).

The goal of this clinical research study is to find a safe and tolerable dose of navlimetostat in combination with pumitamig that can be given to patients with MTAP-deficient advanced non-small cell lung cancer (NSCLC). The effectiveness of the study drugs will also be studied.

Live record on ClinicalTrials.gov →

• General inclusion criteria
• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of navlimetostat in combination with pumitamig in patients <18 years of age, children are excluded from this study.
• Have at least one measurable lesion as the target lesion based on RECIST v1.1. Lesions treated with prior local treatment (radiation, ablation, etc) are generally not considered target lesions. If the lesion with prior local treatment is the only target lesion, evidence must be provided to demonstrate disease progression.
• MTAP loss as defined by homozygous deletion on NGS and/or by absent MTAP protein expression by IHC. Test can be performed on an archival tissue. External testing by a commercial vendor (e.g. Foundation Medicine, Caris, BostonGene, Tempus) or internal assay (e.g. UT MD Anderson MAPP or IHC) is accepted.
• ECOG performance status 0-1.
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.