RecruitingPhase 1NCT06116786
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-small Cell Lung Cancer
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Enrollment
126 participants
Start Date
Nov 27, 2023
Study Type
INTERVENTIONAL
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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
- For Cohort B of Part 2: Previously treated with anti-PD-1/PD-L1 therapy for metastatic disease as the prior line of therapy
- For Cohort C of Part 2: Treatment naïve
- Adequate organ function
Exclusion Criteria4
- Active central nervous system (CNS) disease involvement
- Active autoimmune disease
- Active infection
- History of solid organ or hematologic stem cell transplantation
Interventions
DRUGJNJ-86974680
JNJ-86974680 will be administered.
DRUGCetrelimab
Cetrelimab will be administered.
RADIATIONRadiation Therapy
Radiation therapy will be administered.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT06116786