A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT06667908
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2024-12-06
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.
JNJ-90301900
JNJ-90301900 will be injected intratumorally and/or intranodally.
Durvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.
JNJ-90301900
JNJ-90301900 will be injected intratumorally and/or intranodally.
Durvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
Durvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Interventions
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JNJ-90301900
JNJ-90301900 will be injected intratumorally and/or intranodally.
Durvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Enterprise Innovation Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Locations
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University of Connecticut Health Center
Farmington, Connecticut, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Macquarie University
North Ryde, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Fundacao Pio XII
Barretos, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Hopital De La Cavale Blanche
Brest, , France
Hopital Nord Marseille
Marseille, , France
Hopital Tenon
Paris, , France
Institut Curie
Paris, , France
Gustave Roussy
Villejuif, , France
Prince of Wales Hospital
Shatin, , Hong Kong
Radboud Umcn
Nijmegen, , Netherlands
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Sakarya University Training and Research Hospital
Sakarya, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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90301900NSC2001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-518276-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
90301900NSC2001
Identifier Type: -
Identifier Source: org_study_id