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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-small-Cell Lung
• Intervention / Treatment: Drug: JNJ-86974680; Drug: Cetrelimab; Radiation: Radiation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Completed
    • Charité Research Organisation GmbH
  • Giessen, Germany, 35392
    • Recruiting
    • Universitaetsklinikum Giessen und Marburg GmbH
• South Korea
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Hosp. Univ. Quiron Dexeus
  • Barcelona, Spain, 8035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Valencia, Spain, 46026
    • Recruiting
    • Hosp. Univ. I Politecni La Fe
• United States
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Recruiting
      • City of Hope 1
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
    • New York, New York, United States, 10032
      • Recruiting
      • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Portland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-86974680; JNJ-86974680 will be administered.; Drug: Cetrelimab; Cetrelimab will be administered.
Experimental: 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.	Drug: JNJ-86974680; JNJ-86974680 will be administered.; Drug: Cetrelimab; Cetrelimab will be administered.; Radiation: Radiation Therapy; Radiation therapy will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) by Severity	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.	Up to 2 years 5 months
Number of Participants with Dose Limiting Toxicities (DLTs)	The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.	Up to 2 years 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680	Cmax is defined as maximum observed plasma concentration of JNJ-86974680.	Up to 2 years 5 months
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680	(AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).	Up to 2 years 5 months
Part 2: Overall Response Rate (ORR)	ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks.	Up to 2 years 5 months
Part 2: Complete Response Rate (CRR)	CRR is defined as the proportion of participants with a best response of CR.	Up to 2 years 5 months
Part 2: Duration of Response (DOR)	DoR is defined as the time from the date of first initial documentation of a response to the date of first documented evidence of progression of disease according to immunotherapy response evaluation criteria in solid tumors (iRECIST) or death due to any cause, whichever occurs first.	Up to 2 years 5 months
Part 2: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.	Up to 2 years 5 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation, Inc Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): June 7, 2029

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Radiotherapy
• Other Study ID Numbers: 86974680NSC1001 (Other Identifier: Janssen Research & Development, LLC); 2023-506393-12-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No