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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 le…
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 CenterFarmington, Connecticut
- Yale UniversityNew Haven, Connecticut
- University of MiamiMiami, Florida
- Orlando Health Cancer InstituteOrlando, Florida
- Emory University Winship Cancer InstituteAtlanta, Georgia
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey