RecruitingPhase 1NCT06116786

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

A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-small Cell Lung Cancer


Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Enrollment

126 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • Active central nervous system (CNS) disease involvement
  • Active autoimmune disease
  • Active infection
  • History of solid organ or hematologic stem cell transplantation

Interventions

DRUGJNJ-86974680

JNJ-86974680 will be administered.

DRUGCetrelimab

Cetrelimab will be administered.

RADIATIONRadiation Therapy

Radiation therapy will be administered.


Locations(15)

City of Hope

Newnan, Georgia, United States

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

View Full Details on ClinicalTrials.gov

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NCT06116786