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RecruitingInterventionalPhase 1

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

NCT ID: NCT06116786Sponsor: Johnson & Johnson Enterprise Innovation Inc.Last updated: 2026-05-08

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.

Arms & interventions

  • DrugJNJ-86974680

    JNJ-86974680 will be administered.

  • DrugCetrelimab

    Cetrelimab will be administered.

  • RadiationRadiation Therapy

    Radiation therapy will be administered.

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: Up to 2 years 5 months

Secondary

  • Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680

    Time frame: Up to 2 years 5 months

  • Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680

    Time frame: Up to 2 years 5 months

  • Part 2: Overall Response Rate (ORR)

    Time frame: Up to 2 years 5 months

  • Part 2: Complete Response Rate (CRR)

    Time frame: Up to 2 years 5 months

  • Part 2: Duration of Response (DOR)

    Time frame: Up to 2 years 5 months

  • Part 2: Disease Control Rate (DCR)

    Time frame: Up to 2 years 5 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (7)

City of Hope 1

Newnan, Georgia, 30265

Recruiting

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

Recruiting

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, 10032

Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213

Recruiting

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Recruiting

Next Virginia

Fairfax, Virginia, 22031

Recruiting