Radiation Therapy: Radiation therapy will be administered.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Active central nervous system (CNS) disease involvement
* Active autoimmune disease
* Active infection
* History of solid organ or hematologic stem cell transplantation
Primary outcome measure(s)
Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years 5 months 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) — Up to 2 years 5 months The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Trial sites (15)
Facility
City
Region
Status
City of Hope 1
Newnan
Georgia
Hackensack University Medical Center
Hackensack
New Jersey
Roswell Park Comprehensive Cancer Center
Buffalo
New York
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York
New York
Providence Portland Medical Center
Portland
Oregon
Thomas Jefferson University
Philadelphia
Pennsylvania
Next Virginia
Fairfax
Virginia
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
More Johnson & Johnson Enterprise Innovation Inc. trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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