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A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06667908.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital Midtown
Status: Active
Name Not Available
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationJohnson & Johnson Enterprise Innovation Inc.