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NCT06667908PHASE2Recruiting

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

Johnson & Johnson Enterprise Innovation Inc.

Start Date

12/6/2024

Completion Date

12/31/2028

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-90301900

BIOLOGICAL

Durvalumab

RADIATION

Concurrent Chemo/Radiation Therapy (cCRT)

DRUG

Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

DRUG

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Interested in This Trial?

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Conditions

Carcinoma, Non-Small-Cell Lung

Locations

Moores Cancer Center at UC San Diego Health

La Jolla, California 92037

United States

University of Connecticut Health Center

Farmington, Connecticut 06030

United States

Yale University

New Haven, Connecticut 06519

United States

University of Miami

Miami, Florida 33136

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30306

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Washington University in St Louis

St Louis, Missouri 63130

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

NYU Langone Health

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

FirstHealth of the Carolinas

Pinehurst, North Carolina 28374

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

Royal Brisbane and Women's Hospital

Herston, 4029

Australia

Sir Charles Gairdner Hospital

Nedlands, 6009

Australia

Macquarie University

North Ryde, 2109

Australia

Royal Melbourne Hospital

Parkville, 3050

Australia

Fundacao Pio XII

Barretos, 14784 400

Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, 01308 050

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05651 901

Brazil

Dongguan People s Hospital

Dongguan, 523109

China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080

China

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, 250117

China

Hopital De La Cavale Blanche

Brest, 29200

France

Hopital Nord Marseille

Marseille, 13015

France

Hopital Tenon

Paris, 75020

France

Institut Curie

Paris, 75248

France

Gustave Roussy

Villejuif, 94805

France

Prince of Wales Hospital

Shatin,

Hong Kong

Antoni van Leeuwenhoek

Amsterdam, 1066 CX

Netherlands

Radboud Umcn

Nijmegen, 6525 GA

Netherlands

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Marmara University Pendik Training Hospital

Istanbul, 34899

Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, 54100

Turkey (Türkiye)

University College London Hospitals

London, NW1 2BU

United Kingdom