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

Last updated: May 2, 2025
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Durvalumab

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

JNJ-90301900

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 IIIA or IIIB NSCLC according to the eighthedition lung 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 andexternal beam radiation therapy (EBRT) 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, major thromboembolic events, clinicallysignificant ventricular arrhythmias or heart failure new york heart associationfunctional classification class III to IV

  • Another concurrent or prior primary malignancy (other than NSCLC) within the last 36months at informed consent

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

  • Active bleeding diathesis or requirement for therapeutic anticoagulation orantiplatelet that cannot be interrupted or altered for procedures

Study Design

Total Participants: 130
Treatment Group(s): 5
Primary Treatment: Durvalumab
Phase: 2
Study Start date:
December 06, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • 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

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 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 Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Active - Recruiting

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