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A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-12-06
Completion Date
2028-12-31
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
JNJ-90301900
JNJ-90301900 will be injected intratumorally and/or intranodally.
Durvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Locations (36)
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
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
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
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