Actively Recruiting
A Phase 2, Randomized, Open-Label Study of JNJ-90301900 with Chemoradiation Followed by Durvalumab in Stage III Unresectable Non-Small Cell Lung Cancer
Led by Johnson & Johnson Enterprise Innovation Inc. · Updated on 2026-06-05
130
Participants Needed
41
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether adding JNJ-90301900 to standard treatment can improve the response rate in people with locally advanced and unresectable stage III non-small cell lung cancer NSCLC. The study focuses on combining this investigational drug with platinum-based chemotherapy and radiation therapy, followed by immunotherapy consolidation. This phase 2 trial aims to assess both the safety and effectiveness of this combination approach compared to standard therapy alone. Participants receive JNJ-90301900 injected directly into tumors or nearby lymph nodes at varying volumes 22 or 33 of gross tumor volume along with concurrent chemotherapy and radiation therapy cCRT. Following this, they undergo consolidation immunotherapy with durvalumab. The study includes experimental groups receiving these injections plus cCRT and consolidation immunotherapy, as well as a control group treated with cCRT and consolidation immunotherapy without JNJ-90301900. During the trial, participants will be closely monitored with independent central reviews assessing objective response rates up to 2 years and 2 months. Additional measures include progression-free survival, duration of response, and safety evaluations such as treatment-emergent adverse events and laboratory tests. The study duration allows detailed tracking of tumor response, disease control, and participant health throughout and after treatment.
CONDITIONS
Brief Title
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for standard treatment of NSCLC by concurrent platinum-based chemotherapy with radiation followed by durvalumab as determined by investigator and local guidelines
- Medical history of pathologically confirmed NSCLC diagnosis within 3 months prior to enrollment
- Locally advanced unresectable stage III NSCLC by the eighth edition lung cancer stage classification
- At least one target lesion suitable for intratumoral or intranodal injection and intensity modulated radiation therapy as determined by investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- History of primary immunodeficiency or organ transplant requiring immunosuppression
- Severe or unstable angina, myocardial infarction, significant ventricular arrhythmias, or heart failure (New York Heart Association class III-IV) within 3 months prior to enrollment
- Another primary malignancy within the last 36 months
- Known allergies or intolerance to JNJ-90301900 crystalline solution, platinum-based chemotherapy, or durvalumab
- History of coagulation disorders including active bleeding or need for anticoagulation that cannot be interrupted for injection procedures
- Major thromboembolic events within 3 months prior to enrollment such as pulmonary embolism or stroke
Research Team
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Study Contact
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