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.
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
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
Parallel
JNJ-90301900
DrugJNJ-90301900 will be injected intratumorally and/or intranodally.
Durvalumab
Biological/VaccineDurvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)
RadiationRadiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
DrugCarboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
DrugPaclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 using ICR assessments.
Objective Response Rate (ORR) Post-cCRT and Pre-cIT
Objective response rate is defined as percentage of participants who achieve CR or PR, post-concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) and pre-consolidation immunotherapy (cIT) based on investigator's assessment according to RECIST v1.1.
Disease Control Rate (DCR) Post-cCRT and Pre-cIT
DCR is defined as percentage of participants who achieve CR, PR and stable disease post-cCRT and pre-cIT based on investigator's assessment according to RECIST v1.1.
Objective Response Rate (ORR) as Assessed by the Investigator
ORR is defined as the percentage of participants who have a best response of CR or PR using RECIST v1.1 as assessed by the investigator.
Progression Free Survival (PFS)
PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1.
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