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

Last Updated February 15, 2025

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86974680NSC1001

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
10 Sites
Status

Recruiting

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.

CONDITIONS

Carcinoma, Non-Small-Cell Lung

ELIGIBILITY

Inclusion 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

Exclusion Criteria:

* 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:

More...

DETAILS

LOCATIONS

Locations in:

United States, Germany, South Korea, Spain

Country (4)	City or Province (10)	Status
United States	Buffalo Roswell Park Comprehensive Cancer Center	RECRUITING
United States	New York Herbert Irving Comprehensive Cancer Center Columbia University Medical Center	RECRUITING
United States	Philadelphia Thomas Jefferson University	RECRUITING
United States	Fairfax Next Virginia	RECRUITING
Germany	Berlin Charite Research Organisation GmbH	RECRUITING
Germany	Giessen Universitaetsklinikum Giessen und Marburg GmbH	RECRUITING
South Korea	Seoul Severance Hospital Yonsei University Health System	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
Spain	Barcelona Hosp. Univ. Quiron Dexeus	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING

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