Recruiting NCT06116786
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JNJ-86974680, Cetrelimab, Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-small-Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, South Korea, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- Drug JNJ-86974680
JNJ-86974680 will be administered. - Drug Cetrelimab
Cetrelimab will be administered. - Radiation Radiation Therapy
Radiation therapy will be administered.
Primary outcome measures
- Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 2 years 5 months]
- Number of Participants with Dose Limiting Toxicities (DLTs) [Time frame: Up to 2 years 5 months]
Secondary outcome measures (6)
- Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680 [Time frame: Up to 2 years 5 months]
- Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680 [Time frame: Up to 2 years 5 months]
- Part 2: Overall Response Rate (ORR) [Time frame: Up to 2 years 5 months]
- Part 2: Complete Response Rate (CRR) [Time frame: Up to 2 years 5 months]
- Part 2: Duration of Response (DOR) [Time frame: Up to 2 years 5 months]
- Part 2: Disease Control Rate (DCR) [Time frame: Up to 2 years 5 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- City of Hope 1 — Newnan
- Hackensack University Medical Center — Hackensack
- Roswell Park Comprehensive Cancer Center — Buffalo
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York
- Providence Portland Medical Center — Portland
- Thomas Jefferson University — Philadelphia
- Next Virginia — Fairfax
Spain · 4 centers
- Hosp. Univ. Quiron Dexeus — Barcelona
- Hosp Univ Vall D Hebron — Barcelona
- Hosp. Univ. 12 de Octubre — Madrid
- Hosp. Univ. I Politecni La Fe — Valencia
Germany · 2 centers
- Charite Research Organisation GmbH — Berlin
- Universitaetsklinikum Giessen und Marburg GmbH — Giessen
South Korea · 2 centers
- Severance Hospital Yonsei University Health System — Seoul
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT06116786 · 86974680NSC1001 · 2023-506393-12-00