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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат JNJ-90301900
  JNJ-90301900 will be injected intratumorally and/or intranodally.
• Биопрепарат Durvalumab
  Durvalumab will be administered as intravenous (IV) infusion as cIT.
• Лучевая терапия Concurrent Chemo/Radiation Therapy (cCRT)
  Radiation by intensity modulated radiation therapy (IMRT) will be administered.
• Препарат Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
  Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
• Препарат Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
  Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

Первичные конечные точки

• Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment [Срок оценки: Up to 2 Years and 2 months]

Вторичные конечные точки (9)

• Objective Response Rate (ORR) Post-cCRT and Pre-cIT [Срок оценки: Up to 12 Weeks]
• Disease Control Rate (DCR) Post-cCRT and Pre-cIT [Срок оценки: Up to 12 Weeks]
• Objective Response Rate (ORR) as Assessed by the Investigator [Срок оценки: Up to 2 Years and 2 months]
• Progression Free Survival (PFS) [Срок оценки: Up to 2 Years and 2 months]
• Duration of Response (DoR) [Срок оценки: Up to 2 Years and 2 months]
• Time to Locoregional Failure (LRF) [Срок оценки: Up to 2 Years and 2 months]
• Time to Distant Failure (DF) [Срок оценки: Up to 2 Years and 2 months]
• Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment [Срок оценки: Up to 2 Years and 2 months]
• Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities [Срок оценки: Up to 2 Years and 2 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 18 центров

• Moores Cancer Center at UC San Diego Health — La Jolla
• University of Connecticut Health Center — Farmington
• Yale University — New Haven
• University of Miami — Miami
• Orlando Health Cancer Institute — Orlando
• Emory University Winship Cancer Institute — Atlanta
• Beth Israel Deaconess Medical Center — Boston
• Washington University in St Louis — St Louis
• … и ещё 10 центров

Франция · 5 центров

• Hopital De La Cavale Blanche — Brest
• Hopital Nord Marseille — Marseille
• Hopital Tenon — Paris
• Institut Curie — Paris
• Gustave Roussy — Villejuif

Австралия · 4 центра

• Royal Brisbane and Women's Hospital — Herston
• Sir Charles Gairdner Hospital — Nedlands
• Macquarie University — North Ryde
• Royal Melbourne Hospital — Parkville

Испания · 4 центра

• Hosp. Univ. 12 de Octubre — Madrid
• Clinica Univ. de Navarra — Pamplona
• Hosp. Clinico Univ. de Santiago — Santiago de Compostela
• Hosp. Univ. I Politecni La Fe — Valencia

Бразилия · 3 центра

• Fundacao Pio XII — Barretos
• Sociedade Beneficente de Senhoras Hospital Sirio Libanes — São Paulo
• Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo

Китай · 3 центра

• Dongguan People s Hospital — Дунгуань
• The First Affiliated Hospital Sun Yat sen University — Гуанчжоу
• The Affiliated Cancer Hospital of Shandong First Medical University — Цзинань

Нидерланды · 2 центра

• Antoni van Leeuwenhoek — Amsterdam
• Radboud Umcn — Nijmegen

Turkey (Türkiye) · 2 центра

• Marmara University Pendik Training Hospital — Istanbul
• Sakarya University Training and Research Hospital — Sakarya

Гонконг · 1 центр

• Prince of Wales Hospital — Shatin

Великобритания · 1 центр

• University College London Hospitals — London

Идентификаторы

NCT: NCT06667908 · 90301900NSC2001 · 90301900NSC2001 · 2024-518276-32-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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