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

Purpose

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.

Condition

  • Carcinoma, Non-small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

City of Hope 1
Newnan, Georgia 30265

Hackensack University Medical Center
Hackensack, New Jersey 07601

Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York 10032

Providence Portland Medical Center
Portland, Oregon 97213

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Next Virginia
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Enterprise Innovation Inc.

Study Contact

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

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.