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

NCT06116786 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 86974680NSC10012023-506393-12-00
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 15

Brief 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.

Conditions

Carcinoma, Non-small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) 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

  Up to 2 years 5 months

• Part 2: Overall Response Rate (ORR)

  Up to 2 years 5 months

• Part 2: Complete Response Rate (CRR)

  Up to 2 years 5 months

• Part 2: Duration of Response (DOR)

  Up to 2 years 5 months

Study Arms (2)

Part 1: JNJ-86974680+Cetrelimab

EXPERIMENTAL

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; Drug: Cetrelimab

Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)

EXPERIMENTAL

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; Drug: Cetrelimab; Radiation: Radiation Therapy

Interventions

JNJ-86974680 DRUG

JNJ-86974680 will be administered.

Part 1: JNJ-86974680+Cetrelimab; Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)

Cetrelimab DRUG

Cetrelimab will be administered.

Part 1: JNJ-86974680+Cetrelimab; Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)

Radiation Therapy RADIATION

Radiation therapy will be administered.

Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Enterprise Innovation Inc.: lead

Study Sites (15)

City of Hope 1

Newnan, Georgia, 30265, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Charite Research Organisation GmbH

Berlin, 12203, Germany

COMPLETED

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, 35392, Germany

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hosp. Univ. Quiron Dexeus

Barcelona, 08028, Spain

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Johnson & Johnson Enterprise Innovation, Inc Clinical Trial

  Johnson & Johnson Enterprise Innovation Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): June 7, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); US (7); DE (2); ES (4)