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Clinical Trials in the USA / NCT06116786
Active, not recruiting Phase 1

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer

NCT06116786 · tracked via the Priya Life Science USA tracker
Sponsor
Johnson & Johnson Enterprise Innovation Inc
Phase
Phase 1
Started
2023-11-27
Last updated
2026-09-25

Condition(s) studied

Carcinoma, Non-small-Cell Lung

Investigational drug(s) / intervention(s)

JNJ-86974680 →Cetrelimab →Radiation Therapy

JNJ-86974680: JNJ-86974680 will be administered.

Cetrelimab: Cetrelimab will be administered.

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)

FacilityCityRegionStatus
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 the USA

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma Recruiting
A Study of JNJ-1761981 in Participants With Solid Tumors Recruiting
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors Recruiting
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC) Recruiting
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC Recruiting

Other trials for the same condition

Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. Active, not recruiting
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1. Recruiting
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Recruiting
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers Active, not recruiting
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) Recruiting
Official registry record

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.

View NCT06116786 on ClinicalTrials.gov ↗ ← All trials in the USA