Status:
RECRUITING
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Johnson & Johnson Enterprise Innovation Inc.
Conditions:
Carcinoma, Non-small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- Active central nervous system (CNS) disease involvement
- Active autoimmune disease
- Active infection
- History of solid organ or hematologic stem cell transplantation
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2029
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06116786
Start Date
November 27 2023
End Date
June 7 2029
Last Update
December 5 2025
Active Locations (15)
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1
City of Hope
Newnan, Georgia, United States, 30265
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
4
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States, 10032