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Carcinoma, Non-small-Cell LungPhase 1NCT06116786

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

A Phase 1 study testing JNJ-86974680, Cetrelimab and Radiation Therapy in people with Carcinoma, Non-small-Cell Lung, run by Johnson & Johnson Enterprise Innovation Inc. at 15 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-small-Cell Lung
What is being tested?
JNJ-86974680, Cetrelimab and Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
15 sitesin 4 countries
Study dates
27 Nov 2023to 31 Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States7 sites

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

  • Next Virginia

    Fairfax, Virginia, 22031

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York, 10032

  • City of Hope 1

    Newnan, Georgia, 30265

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Providence Portland Medical Center

    Portland, Oregon, 97213

Other trials in United States

Spain4 sites

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Germany2 sites

  • Charite Research Organisation GmbH

    Berlin, 12203

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

Other trials in Germany

South Korea2 sites

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official 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

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.

Read the 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.

Being tested
JNJ-86974680, Cetrelimab, Radiation Therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-86974680Drug

    JNJ-86974680 will be administered.

  • CetrelimabDrug

    Cetrelimab will be administered.

  • Radiation TherapyRadiation

    Radiation therapy will be administered.

Study groups in NCT06116786
Study groupRoleWhat they receive
Part 1: JNJ-86974680+CetrelimabExperimentalParticipants 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.
Receives: Drug: JNJ-86974680; Drug: Cetrelimab
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)ExperimentalPart 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.
Receives: Drug: JNJ-86974680; Drug: Cetrelimab; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years 5 months

  2. 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.

    Measured: Up to 2 years 5 months

Secondary outcomes (6)

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

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

    Measured: Up to 2 years 5 months

  2. 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).

    Measured: Up to 2 years 5 months

  3. 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.

    Measured: Up to 2 years 5 months

  4. Part 2: Complete Response Rate (CRR)

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

    Measured: Up to 2 years 5 months

  5. 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.

    Measured: Up to 2 years 5 months

  6. 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.

    Measured: Up to 2 years 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start27 Nov 2023
  3. Primary completion14 Apr 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06116786
Sponsor's protocol ID
86974680NSC1001
Other IDs
2023-506393-12-00, 2023
Status last verified
Nov 2026
First submitted
31 Oct 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-86974680, Cetrelimab and Radiation Therapy in people with Carcinoma, Non-small-Cell Lung, run by Johnson & Johnson Enterprise Innovation Inc. at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Spain, Germany, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) by Severity (time frame: Up to 2 years 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06116786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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