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RECRUITING Phase 2 ClinicalTrials.gov

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Johnson & Johnson Enterprise Innovation Inc. • ClinicalTrials.gov ID: NCT06667908

Registry updated: 2026-09-25
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Description

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.

Interventions

  • JNJ-90301900 (Drug)
    JNJ-90301900 will be injected intratumorally and/or intranodally.
  • Durvalumab (Biological)
    Durvalumab will be administered as intravenous (IV) infusion as cIT.
  • Concurrent Chemo/Radiation Therapy (cCRT) (Radiation)
    Radiation by intensity modulated radiation therapy (IMRT) will be administered.
  • Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin (Drug)
    Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
  • Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel (Drug)
    Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

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

Conditions

Carcinoma, Non-Small-Cell Lung

Locations

  • Moores Cancer Center at UC San Diego Health — La Jolla, California, United States
  • University of Connecticut Health Center — Farmington, Connecticut, United States
  • Yale University — New Haven, Connecticut, United States
  • University of Miami — Miami, Florida, United States
  • Orlando Health Cancer Institute — Orlando, Florida, United States
  • Emory University Winship Cancer Institute — Atlanta, Georgia, United States
  • Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
  • Washington University in St Louis — St Louis, Missouri, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, 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 Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • Oregon Health And Science University — Portland, Oregon, 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
  • Royal Brisbane and Women's Hospital — Herston, Australia
  • Sir Charles Gairdner Hospital — Nedlands, Australia
  • 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
  • Dongguan People s Hospital — Dongguan, China
  • The First Affiliated Hospital Sun Yat sen University — Guangzhou, China
  • The Affiliated Cancer Hospital of Shandong First Medical University — Jinan, China
  • Hopital De La Cavale Blanche — Brest, France
  • Hopital Nord Marseille — Marseille, France
  • Hopital Tenon — Paris, France
  • Institut Curie — Paris, France
  • CHU Rouen Hopital Charles Nicolle — Rouen, France
  • Gustave Roussy — Villejuif, France
  • Prince of Wales Hospital — Shatin, Hong Kong
  • Antoni van Leeuwenhoek — Amsterdam, Netherlands
  • 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
  • Marmara University Pendik Training Hospital — Istanbul, Turkey (Türkiye)
  • Sakarya University Training and Research Hospital — Sakarya, Turkey (Türkiye)
  • University College London Hospitals — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record