Testing JNJ-86974680 for advanced non-small cell lung cancer
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
This study is testing a new treatment combining JNJ-86974680 with cetrelimab and radiation therapy to see if it helps people with advanced non-small cell lung cancer who have already tried other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johnson & Johnson Enterprise Innovation Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, cetrelimab, radiation |
| Locations | 15 sites (Newnan, Georgia and 14 other locations) |
| Trial ID | NCT06116786 on ClinicalTrials.gov |
What this trial studies
This study aims to find a safe and tolerable dose of JNJ-86974680 when used in combination with cetrelimab and radiation therapy for patients with advanced non-small cell lung cancer (NSCLC). It includes participants with confirmed stage IIIB-IV NSCLC, focusing on those with actionable genetic mutations who have progressed after standard therapies. The study is divided into different cohorts based on prior treatments and genetic profiles to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals with advanced non-small cell lung cancer who have previously received standard therapies and have specific genetic mutations or have progressed after treatment.
Not a fit: Patients with early-stage non-small cell lung cancer or those who have not received prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced non-small cell lung cancer who have limited alternatives.
How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies and radiation in treating advanced lung cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newnan, Georgia and 14 other locations
- City of Hope 1 — Newnan, Georgia, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States (Recruiting)
- Providence Portland Medical Center — Portland, Oregon, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- Next Virginia — Fairfax, Virginia, United States (Recruiting)
- Charite Research Organisation GmbH — Berlin, Germany (Completed)
- Universitaetsklinikum Giessen und Marburg GmbH — Giessen, Germany (Recruiting)
- Severance Hospital Yonsei University Health System — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Hosp. Univ. Quiron Dexeus — Barcelona, Spain (Recruiting)
- Hosp Univ Vall D Hebron — Barcelona, Spain (Recruiting)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (Recruiting)
- Hosp. Univ. I Politecni La Fe — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.