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A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
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 NSCLC
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- JNJ-90301900 (drug)
- Durvalumab (biological)
- Concurrent Chemo/Radiation Therapy (cCRT) (radiation)
- Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin (drug)
- Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel (drug)
Sponsor: Johnson & Johnson Enterprise Innovation Inc. · Participants: 130 · Started: Dec 6, 2024
Contact the study team
- Study Contact · Phone: 844-434-4210
Official record on ClinicalTrials.gov — NCT06667908
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.