A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
NCT ID: NCT06116786
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
126 participants
INTERVENTIONAL
2023-11-27
2029-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: JNJ-86974680+Cetrelimab
Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab.
JNJ-86974680
JNJ-86974680 will be administered.
Cetrelimab
Cetrelimab will be administered.
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.
JNJ-86974680
JNJ-86974680 will be administered.
Cetrelimab
Cetrelimab will be administered.
Radiation Therapy
Radiation therapy will be administered.
Interventions
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JNJ-86974680
JNJ-86974680 will be administered.
Cetrelimab
Cetrelimab will be administered.
Radiation Therapy
Radiation therapy will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Active autoimmune disease
* Active infection
* History of solid organ or hematologic stem cell transplantation
18 Years
ALL
No
Sponsors
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Johnson & Johnson Enterprise Innovation Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Enterprise Innovation, Inc Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Locations
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Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Next Virginia
Fairfax, Virginia, United States
Charite Research Organisation GmbH
Berlin, , Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. Univ. Quiron Dexeus
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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86974680NSC1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506393-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
86974680NSC1001
Identifier Type: -
Identifier Source: org_study_id