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 non-small cell lung cancer
Primary
To determine whether JNJ-90301900 as a radioenhancer added to cCRT followed by
cIT can improve objective response rate (ORR) in participantswith locally
advanced and unresectable Stage III NSCLC
Secondary
To assess additional measures of clinical benefit in participants treated with
JNJ-90301900 in combination with standard of carecCRTfollowed by cIT
To assess the locoregionaland distant effects of JNJ-90301900 as a radioenhancer to cCRT
To assess the safety and tolerability profile of JNJ-90301900 as a radioenhancer to
cCRT
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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