RecruitingPhase 2NCT06667908

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Enrollment

130 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study adds a new drug called JNJ-90301900 (injected directly into the tumor) to the standard treatment for inoperable stage III non-small cell lung cancer. The standard treatment is chemotherapy plus radiation followed by immunotherapy (durvalumab). The goal is to see if adding this injection improves results. **You may be eligible if...** - You have confirmed inoperable stage III non-small cell lung cancer - You are a candidate for standard combined chemotherapy and radiation, followed by durvalumab immunotherapy - You have at least one tumor that can be injected directly and is suitable for radiation - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - You have a primary immune deficiency or have had an organ transplant requiring immune-suppressing medications - You had a heart attack, severe heart failure, or serious heart rhythm problem within 3 months - You have another active cancer diagnosed within the last 3 years - You have allergies to any of the study drugs - You have active bleeding disorders or had a major blood clot (e.g., pulmonary embolism, stroke) recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGJNJ-90301900

JNJ-90301900 will be injected intratumorally and/or intranodally.

BIOLOGICALDurvalumab

Durvalumab will be administered as intravenous (IV) infusion as cIT.

RADIATIONConcurrent Chemo/Radiation Therapy (cCRT)

Radiation by intensity modulated radiation therapy (IMRT) will be administered.

DRUGConcurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.

DRUGConcurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

Locations(40)

University of Connecticut Health Center

Farmington, Connecticut, United States

Yale University

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

FirstHealth of the Carolinas

Pinehurst, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Health And Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Royal Brisbane and Women's Hospital

Herston, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

Macquarie University

North Ryde, Australia

Royal Melbourne Hospital

Parkville, Australia

Fundacao Pio XII

Barretos, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Dongguan People s Hospital

Dongguan, China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, China

Hopital De La Cavale Blanche

Brest, France

Hopital Nord Marseille

Marseille, France

Hopital Tenon

Paris, France

Institut Curie

Paris, France

Gustave Roussy

Villejuif, France

Prince of Wales Hospital

Shatin, Hong Kong

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Radboud Umcn

Nijmegen, Netherlands

Hosp. Univ. 12 de Octubre

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Marmara University Pendik Training Hospital

Istanbul, Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, Turkey (Türkiye)

University College London Hospitals

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06667908