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

About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Navtemadlin
Eligibility Criteria
Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of NSCLC documented as TP53WT Locally 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 V1.1 Adequate hematologic, hepatic and renal function (within 14 days) Exclusion Criteria: Symptomatic or uncontrolled central nervous system (CNS) metastases Prior treatment with a MDM2 inhibitor Grade 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 weeks History of major organ transplant Active pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis Prior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 days Medical 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Navtemadlin in combination with pembrolizumab
Navtemadlin placebo in combination with pembrolizumab
Navtemadlin will be administered orally, once daily (QD), on days 1-7 in a 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of a 21-day cycle.
Navtemadlin placebo will be administered orally, once daily (QD), on days 1-7 in a 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of a 21-day cycle.