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Набира участници Фаза 2 NCT06667908

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Carcinoma, Non-Small-Cell Lung

Спонсор: Johnson & Johnson Enterprise Innovation Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 10
Австралия (1)
Royal Brisbane and Women's Hospital
Herston
Бразилия (1)
Fundacao Pio XII
Barretos
Китай (1)
Dongguan People s Hospital
Dongguan
Франция (1)
Hopital De La Cavale Blanche
Brest
Hong Kong (1)
Prince of Wales Hospital
Shatin
Нидерландия (1)
Antoni van Leeuwenhoek
Amsterdam
Испания (1)
Hosp. Univ. 12 de Octubre
Madrid
Турция (1)
Marmara University Pendik Training Hospital
Istanbul
Великобритания (1)
University College London Hospitals
London
САЩ (1)
University of Connecticut Health Center
Farmington , Connecticut
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
06.12.2024
Крайна дата
31.12.2028
Регистрационен номер
NCT06667908
Източник
anzctr
Запитване за медицински туризъм

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