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

Recruiting now · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT06667908

Run by

Johnson & Johnson Enterprise Innovation Inc.

People needed

130

Starts

2024-12-06

Expected to finish

2028-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moores Cancer Center at UC San Diego Health — La Jolla, California, United States (enrolling)
• University of Connecticut Health Center — Farmington, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Washington University in St Louis — St Louis, Missouri, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• FirstHealth of the Carolinas — Pinehurst, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Oregon Health And Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Vermont Medical Center — Burlington, Vermont, United States (enrolling)
• Royal Brisbane and Women's Hospital — Herston, Australia (enrolling)
• Sir Charles Gairdner Hospital — Nedlands, Australia (enrolling)
• Macquarie University — North Ryde, Australia (enrolling)
• Royal Melbourne Hospital — Parkville, Australia (enrolling)
• Fundacao Pio XII — Barretos, Brazil (enrolling)
• Sociedade Beneficente de Senhoras Hospital Sirio Libanes — São Paulo, Brazil (enrolling)
• Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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