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NCT Number: NCT06116786

A Study of JNJ-86974680 in Participants With 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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charite Research Organisation GmbH, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-86974680

Drug

JNJ-86974680 will be administered.

Cetrelimab

Drug

Cetrelimab will be administered.

radiation therapy

Radiation

Radiation therapy will be administered.

Primary outcomes

  1. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to 2 years 5 months

    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.

  2. Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 2 years 5 months

    The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680

    Time frame: Up to 2 years 5 months

    Cmax is defined as maximum observed plasma concentration of JNJ-86974680.

  2. 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

    (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).

  3. Part 2: Overall Response Rate (ORR)

    Time frame: Up to 2 years 5 months

    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.

  4. Part 2: Complete Response Rate (CRR)

    Time frame: Up to 2 years 5 months

    CRR is defined as the proportion of participants with a best response of CR.

  5. Part 2: Duration of Response (DOR)

    Time frame: Up to 2 years 5 months

    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.

  6. Part 2: Disease Control Rate (DCR)

    Time frame: Up to 2 years 5 months

    DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Nov 3, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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