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.

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

Carcinoma, Non-small-Cell Lung

Carcinoma, Non-Small-Cell Lung

Carcinoma, Non-Small Cell Lung

Non-Small Cell Lung Cancer

Non-Small-Cell Lung Carcinoma

Lung Cancer

Lung; Node

Cancer of the Lung

Cancer of Lung

Neoplasms, Lung

Lung Neoplasms

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

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.

Cetrelimab

Radiation Therapy

JNJ-86974680

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

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.

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

Cmax is defined as maximum observed plasma concentration 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).

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.

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

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.

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

Participants 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.

Part 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.

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.

Hackensack University Medical Center

Roswell Park Comprehensive Cancer Center

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

Thomas Jefferson University

Next Virginia

Charite Research Organisation GmbH

Universitaetsklinikum Giessen und Marburg GmbH

Severance Hospital Yonsei University Health System

Samsung Medical Center

Hosp. Univ. Quiron Dexeus

Hosp Univ Vall D Hebron

Hosp. Univ. 12 de Octubre

Hosp. Univ. I Politecni La Fe

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

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.

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

(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).

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.

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.

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

Participants 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.

Part 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.

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

Trials at a glance

Trials at a glance