Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.

Inclusion Criteria:ECOG 0-1Histologically or cytologically confirmed diagnosis of NSCLC documented as TP53WTLocally advanced or metastatic disease; must have completed up to 4 cycles of platinum-based chemo plus CPI and achieved a CR or PR per RECIST V1.1Adequate hematologic, hepatic and renal function (within 14 days)Exclusion Criteria:Symptomatic or uncontrolled central nervous system (CNS) metastasesPrior treatment with a MDM2 inhibitorGrade 2 or higher QTc prolongation (>480 msec per NCI-CTCAE criteria version 5.0)History of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeksHistory of major organ transplantActive pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitisPrior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 daysMedical condition, serious intercurrent illness, psychiatric condition or other circumstance that, in the Investigator's judgment could jeopardize the subject's safety, or that could interfere with study objectives