The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.
Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)
Part 1: NSCLC with a known actionable genetic mutation (for example, epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], c-ros oncogene 1 [ROS1], v-raf murine sarcoma viral oncogene homolog B1 [BRAF]) must have received all approved targeted therapies and have progressed
Part 2: No targetable mutations (for example, EGFR [epidermal growth factor receptor], ALK [anaplastic lymphoma kinase], ROS1[c-ros oncogene 1], and BRAF [B-Raf proto-oncogene, serine/threonine kinase])
Part 1 and Cohort A of part 2: Must have been treated with (a) anti-programmed death protein 1 (anti-PD-1) or programmed cell death ligand 1 (PD-L1) therapy and (b) platinum-based chemotherapy
Active central nervous system (CNS) disease involvement
Active autoimmune disease
Active infection
History of solid organ or hematologic stem cell transplantation
Sequential
JNJ-86974680
DrugJNJ-86974680 will be administered.
Cetrelimab
DrugCetrelimab will be administered.
Radiation Therapy
RadiationRadiation therapy will be administered.
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Number of Participants with Dose Limiting Toxicities (DLTs)
The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680
Cmax is defined as maximum observed plasma concentration of JNJ-86974680.
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680
(AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).
Part 2: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks.
Part 2: Complete Response Rate (CRR)
CRR is defined as the proportion of participants with a best response of CR.
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