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Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: JNJ-90301900, Durvalumab, Concurrent Chemo/Radiation Therapy (cCRT), Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin, Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Countries: United States, Australia, Brazil, China, France, Hong Kong, Netherlands, Spain
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- La Jolla, California, United States
- Farmington, Connecticut, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Pinehurst, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Burlington, Vermont, United States
- Herston, Australia
- Nedlands, Australia
- North Ryde, Australia
- Parkville, Australia
- Barretos, Brazil
- São Paulo, Brazil
- São Paulo, Brazil
- Dongguan, China
- Guangzhou, China
- Jinan, China
- Brest, France
- Marseille, France
- + 13 more on CT.gov