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NCT06116786PHASE1Recruiting

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

Johnson & Johnson Enterprise Innovation Inc.

Start Date

11/27/2023

Completion Date

6/7/2029

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.

Detailed Description

Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion), post-treatment follow-up period, and long-term extension period.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-86974680

DRUG

Cetrelimab

RADIATION

Radiation Therapy

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Conditions

Carcinoma, Non-small-Cell Lung

Locations

City of Hope 1

Newnan, Georgia 30265

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14203

United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York 10032

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Next Virginia

Fairfax, Virginia 22031

United States

Charite Research Organisation GmbH

Berlin, 12203

Germany

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, 35392

Germany

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hosp. Univ. Quiron Dexeus

Barcelona, 08028

Spain

Hosp Univ Vall D Hebron

Barcelona, 8035

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain