Clinical trial NCT06116786: A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Carcinoma, Non-small-Cell Lung
Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to 2 years 5 months
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680
timeFrame: Up to 2 years 5 months
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680
timeFrame: Up to 2 years 5 months
measure: Part 2: Overall Response Rate (ORR)
timeFrame: Up to 2 years 5 months
measure: Part 2: Complete Response Rate (CRR)
timeFrame: Up to 2 years 5 months
measure: Part 2: Duration of Response (DOR)
timeFrame: Up to 2 years 5 months
measure: Part 2: Disease Control Rate (DCR)
timeFrame: Up to 2 years 5 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Fairfax
country: United States
facility: Next Virginia
state: Virginia
city: Berlin
country: Germany
facility: Charite Research Organisation GmbH
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Barcelona
country: Spain
facility: Hosp. Univ. Quiron Dexeus
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
Study officials:
affiliation: Johnson & Johnson Enterprise Innovation Inc.
name: Johnson & Johnson Enterprise Innovation, Inc Clinical Trial
role: STUDY_DIRECTOR
References: