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Recruiting Phase 2 NCT06667908

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

Phase 2 – studying effectiveness and dosage
Conditions: Carcinoma, Non-Small-Cell Lung

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

trial.available_in: БГ
Overview
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 participate
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
Locations 10
Australia (1)
Royal Brisbane and Women's Hospital
Herston
Brazil (1)
Fundacao Pio XII
Barretos
China (1)
Dongguan People s Hospital
Dongguan
France (1)
Hopital De La Cavale Blanche
Brest
Hong Kong (1)
Prince of Wales Hospital
Shatin
Netherlands (1)
Antoni van Leeuwenhoek
Amsterdam
Spain (1)
Hosp. Univ. 12 de Octubre
Madrid
Turkey (1)
Marmara University Pendik Training Hospital
Istanbul
United Kingdom (1)
University College London Hospitals
London
United States (1)
University of Connecticut Health Center
Farmington , Connecticut
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.12.2024
Completion date
31.12.2028
Registry ID
NCT06667908
Source
anzctr
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