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

NCT06667908 · Johnson & Johnson Enterprise Innovation Inc.
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Official title
A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC
About this study
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 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
Study design
Enrollment target: 130 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-06
Estimated completion: 2028-12-31
Last updated: 2026-04-14
Interventions
Drug: JNJ-90301900Biological: DurvalumabRadiation: Concurrent Chemo/Radiation Therapy (cCRT)Drug: Concurrent Chemo/Radiation Therapy (cCRT): CarboplatinDrug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Primary outcomes
  • Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment (Up to 2 Years and 2 months)
Sponsor
Johnson & Johnson Enterprise Innovation Inc. · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJohnson & Johnson Enterprise Innovation Inc. Clinical Trial · study_director, Johnson & Johnson Enterprise Innovation Inc.
All locations (40)
University of Connecticut Health CenterRecruiting
Farmington, Connecticut, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
University of MiamiRecruiting
Miami, Florida, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
Emory University Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
FirstHealth of the CarolinasRecruiting
Pinehurst, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Oregon Health And Science UniversityRecruiting
Portland, Oregon, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
Royal Brisbane and Women's HospitalRecruiting
Herston, Australia
Sir Charles Gairdner HospitalRecruiting
Nedlands, Australia
Macquarie UniversityRecruiting
North Ryde, Australia
Royal Melbourne HospitalRecruiting
Parkville, Australia
Fundacao Pio XIIRecruiting
Barretos, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio LibanesRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Dongguan People s HospitalRecruiting
Dongguan, China
The First Affiliated Hospital Sun Yat sen UniversityRecruiting
Guangzhou, China
The Affiliated Cancer Hospital of Shandong First Medical UniversityRecruiting
Jinan, China
Hopital De La Cavale BlancheRecruiting
Brest, France
Hopital Nord MarseilleRecruiting
Marseille, France
Hopital TenonRecruiting
Paris, France
Institut CurieRecruiting
Paris, France
Gustave RoussyRecruiting
Villejuif, France
Prince of Wales HospitalRecruiting
Shatin, Hong Kong
Antoni van LeeuwenhoekRecruiting
Amsterdam, Netherlands
Radboud UmcnRecruiting
Nijmegen, Netherlands
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Clinica Univ. de NavarraRecruiting
Pamplona, Spain
Hosp. Clinico Univ. de SantiagoRecruiting
Santiago de Compostela, Spain
Hosp. Univ. I Politecni La FeRecruiting
Valencia, Spain
Marmara University Pendik Training HospitalRecruiting
Istanbul, Turkey (Türkiye)
Sakarya University Training and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
University College London HospitalsRecruiting
London, United Kingdom
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC) · TrialPath