A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
Recruiting · NCT06667908 · Interventional (participants receive a specific treatment) · Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Concurrent Chemo/Radiation Therapy (cCRT)Concurrent Chemo/Radiation Therapy (cCRT): CarboplatinConcurrent Chemo/Radiation Therapy (cCRT): PaclitaxelDurvalumabJNJ-90301900
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
- Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
- Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
- Have at least 1 target lesion (primary lung lesion or involved lymph node\[s\]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Exclusion criteria
- Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
- Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
- Another concurrent or prior primary malignancy within the last 36 months at informed consent
- Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
- History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization
Where it is running
43 locations listed across 14 US states.
- Moores Cancer Center at UC San Diego Health - La Jolla, California, United States
- 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
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Washington University in St Louis - St Louis, Missouri, 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
- Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Fundacao Pio XII - Barretos, Brazil
- Hopital De La Cavale Blanche - Brest, France
- Dongguan People s Hospital - Dongguan, China
- The First Affiliated Hospital Sun Yat sen University - Guangzhou, China
- Royal Brisbane and Women's Hospital - Herston, Australia
- Marmara University Pendik Training Hospital - Istanbul, Turkey (Türkiye)
- The Affiliated Cancer Hospital of Shandong First Medical University - Jinan, China
- University College London Hospitals - London, United Kingdom
- Hosp. Univ. 12 de Octubre - Madrid, Spain
- Hopital Nord Marseille - Marseille, France
- Sir Charles Gairdner Hospital - Nedlands, Australia
- Radboud Umcn - Nijmegen, Netherlands
- Macquarie University - North Ryde, Australia
- Clinica Univ. de Navarra - Pamplona, Spain
- Hopital Tenon - Paris, France
- Institut Curie - Paris, France
- Royal Melbourne Hospital - Parkville, Australia
- Sakarya University Training and Research Hospital - Sakarya, Turkey (Türkiye)
- Hosp. Clinico Univ. de Santiago - Santiago de Compostela, Spain
- Prince of Wales Hospital - Shatin, Hong Kong
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes - São Paulo, Brazil
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein - São Paulo, Brazil
- Hosp. Univ. I Politecni La Fe - Valencia, Spain
- Gustave Roussy - Villejuif, France