RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-27

Study Completion:2028-08-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06116786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC) * 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 and have progressed. Individuals who cannot tolerate or have previously refused platinum-based chemotherapy are eligible to enroll based on progression after anti-PD-1/PD-L1 therapy alone * Can have a prior or concurrent second malignancy (other than the disease under study), which due to natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Adequate liver function: 1. Participants with no underlying hepatic metastases are eligible if they have: i) aspartate aminotransferase (AST) less than (\<)3 x upper limit of normal (ULN), ii) alanine aminotransferase (ALT) \<3 x ULN, and iii) Total bilirubin \<1.5 x ULN 2. Participants with known hepatic metastases are eligible if they have: i) AST \<5 x ULN, ii) ALT \<5 x ULN, and iii) Total bilirubin \<3 x ULN * 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. Participants with unknown mutation status due to a failed testing status or lack of access to testing are allowed in the study * Part 2: Participants must have at least 3 lesions on baseline scan, one of which is evaluable as a target lesion for response assessment per RECIST Version 1.1 * Part 2: Agree to submit tumor samples prior to study treatment which can be an archival tumor tissue sample obtained within 3 months prior to start of treatment and without any therapy for NSCLC being administered within these 3 months, or newly obtained core or incisional biopsy of a tumor lesion during screening	* Active disease involvement of the central nervous system with the exception of definitively locally treated brain metastases that are clinically stable * Active autoimmune disease that requires systemic immunosuppressive medications (for example, chronic corticosteroid, methotrexate, or tacrolimus) within the 12 months prior to signing consent * Active infection or condition that requires treatment with systemic anti-infective agents (for example, antibiotics, antifungal or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents * History of solid organ or hematologic stem cell transplantation * Part 2: NSCLC with an actionable genetic mutation for which an approved therapy is available: EGFR, ALK, ROS1, or BRAF. Confirmation of the absence of actionable mutations is required

Inclusion Criteria

Exclusion Criteria

* Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)
* 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 and have progressed. Individuals who cannot tolerate or have previously refused platinum-based chemotherapy are eligible to enroll based on progression after anti-PD-1/PD-L1 therapy alone
* Can have a prior or concurrent second malignancy (other than the disease under study), which due to natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Adequate liver function:
1. Participants with no underlying hepatic metastases are eligible if they have: i) aspartate aminotransferase (AST) less than (\<)3 x upper limit of normal (ULN), ii) alanine aminotransferase (ALT) \<3 x ULN, and iii) Total bilirubin \<1.5 x ULN
2. Participants with known hepatic metastases are eligible if they have: i) AST \<5 x ULN, ii) ALT \<5 x ULN, and iii) Total bilirubin \<3 x ULN
* 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. Participants with unknown mutation status due to a failed testing status or lack of access to testing are allowed in the study
* Part 2: Participants must have at least 3 lesions on baseline scan, one of which is evaluable as a target lesion for response assessment per RECIST Version 1.1
* Part 2: Agree to submit tumor samples prior to study treatment which can be an archival tumor tissue sample obtained within 3 months prior to start of treatment and without any therapy for NSCLC being administered within these 3 months, or newly obtained core or incisional biopsy of a tumor lesion during screening

* Active disease involvement of the central nervous system with the exception of definitively locally treated brain metastases that are clinically stable
* Active autoimmune disease that requires systemic immunosuppressive medications (for example, chronic corticosteroid, methotrexate, or tacrolimus) within the 12 months prior to signing consent
* Active infection or condition that requires treatment with systemic anti-infective agents (for example, antibiotics, antifungal or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
* History of solid organ or hematologic stem cell transplantation
* Part 2: NSCLC with an actionable genetic mutation for which an approved therapy is available: EGFR, ALK, ROS1, or BRAF. Confirmation of the absence of actionable mutations is required

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study@its.jnj.com

Principal Investigator

Johnson & Johnson Enterprise Innovation, Inc Clinical Trial

STUDY_DIRECTOR

Johnson & Johnson Enterprise Innovation Inc.

Study Locations (Sites)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, 10032

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Next Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Johnson & Johnson Enterprise Innovation, Inc Clinical Trial, STUDY_DIRECTOR, Johnson & Johnson Enterprise Innovation Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2028-08-03

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2028-08-03

Terms related to this study

Additional Relevant MeSH Terms

Carcinoma, Non-small-Cell Lung