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

Last updated: March 4, 2026
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

JNJ-90301900

Concurrent Chemo/Radiation Therapy (cCRT)

Clinical Study ID

NCT06667908
90301900NSC2001
2024-518276-32-00
90301900NSC2001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be a candidate for standard of care (SOC) treatment of non small cell lungcancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiationtherapy (cCRT) followed by consolidation durvalumab treatment as determined by theinvestigator and per local guidelines at screening

  • Have a medical history of pathologically (histologically or cytologically) provendiagnosis of NSCLC within 3 months prior to enrollment/randomization

  • Have locally advanced unresectable stage III NSCLC according to the eighth editionlung cancer stage classification

  • Have at least 1 target lesion (primary lung lesion or involved lymph node[s]) perRECIST version 1.1 that is amenable to intratumoral and/or intranodal injection andintensity modulated radiation therapy (IMRT) as determined by the investigator atscreening

  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion

Exclusion Criteria:

  • Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requirestherapeutic immunosuppression

  • Any of the following within 3 months prior to enrollment/randomization: severe orunstable angina, myocardial infarction, clinically significant ventriculararrhythmias or heart failure New York heart association functional classificationclass III to IV

  • Another concurrent or prior primary malignancy within the last 36 months at informedconsent

  • Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab

  • History of coagulation disorders, including: (a) Active bleeding diathesis orrequirement for therapeutic anticoagulation or antiplatelet that cannot beinterrupted or altered for JNJ-90301900 injection procedures, (b) Majorthromboembolic events (for example, pulmonary embolism, cerebrovascular accident)within 3 months of enrollment or randomization

Study Design

Total Participants: 130
Treatment Group(s): 5
Primary Treatment: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Phase: 2
Study Start date:
December 06, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Sir Charles Gairdner Hospital

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands 2064874, 6009
    Australia

    Site Not Available

  • Macquarie University

    North Ryde, 2109
    Australia

    Active - Recruiting

  • Macquarie University

    North Ryde 7281782, 2109
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, 3050
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville 2153770, 3050
    Australia

    Site Not Available

  • Fundacao Pio XII

    Barretos, 14784 400
    Brazil

    Active - Recruiting

  • Fundacao Pio XII

    Barretos 3470451, 14784 400
    Brazil

    Site Not Available

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651 901
    Brazil

    Active - Recruiting

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 050
    Brazil

    Active - Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo 3448439, 05651 901
    Brazil

    Active - Recruiting

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo 3448439, 01308 050
    Brazil

    Site Not Available

  • The Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, 250117
    China

    Active - Recruiting

  • Hopital De La Cavale Blanche

    Brest, 29200
    France

    Active - Recruiting

  • Hopital De La Cavale Blanche

    Brest 3030300, 29200
    France

    Site Not Available

  • Hopital Nord Marseille

    Marseille, 13015
    France

    Active - Recruiting

  • Hopital Nord Marseille

    Marseille 2995469, 13015
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75020
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Hopital Tenon

    Paris 2988507, 75020
    France

    Active - Recruiting

  • Institut Curie

    Paris 2988507, 75248
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Prince of Wales Hospital

    Shatin,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    Shatin 1818920,
    Hong Kong

    Site Not Available

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam 2759794, 1066 CX
    Netherlands

    Site Not Available

  • Radboud Umcn

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Radboud Umcn

    Nijmegen 2750053, 6525 GA
    Netherlands

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela 3109642, 15706
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Medipol Acibadem Bolge Hastanesi

    Istanbul, 34718
    Turkey

    Site Not Available

  • Marmara University Pendik Training Hospital

    Istanbul, 34899
    Turkey (Türkiye)

    Active - Recruiting

  • Marmara University Pendik Training Hospital

    Istanbul 745044, 34899
    Turkey (Türkiye)

    Site Not Available

  • Sakarya University Training and Research Hospital

    Sakarya, 54100
    Turkey (Türkiye)

    Active - Recruiting

  • Sakarya University Training and Research Hospital

    Sakarya 302114, 54100
    Turkey (Türkiye)

    Site Not Available

  • University College London Hospitals

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London 2643743, NW1 2BU
    United Kingdom

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • University of Connecticut Health Center

    Farmington 4834272, Connecticut 4831725 06030
    United States

    Site Not Available

  • Yale University

    New Haven 4839366, Connecticut 4831725 06519
    United States

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Emory University Winship Cancer Institute

    Atlanta, Georgia 30306
    United States

    Active - Recruiting

  • Emory University Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30306
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • FirstHealth of the Carolinas

    Pinehurst, North Carolina 28374
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • FirstHealth of the Carolinas

    Pinehurst 4485272, North Carolina 4482348 28374
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Oregon Health And Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Health And Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington 5234372, Vermont 5242283 05401
    United States

    Site Not Available

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