A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer

Официальное название

A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Обзор

Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide. In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Вмешательства

• Препарат ABBV-706
  Intravenous (IV) Infusion
• Препарат Atezolizumab
  IV Infusion
• Препарат Etoposide
  IV Infusion
• Препарат Carboplatin
  IV Injection
• Препарат Carboplatin
  IV Infusion
• Препарат Lurbinectedin
  IV Infusion

Первичные конечные точки

• Number of Participants with Adverse Events (AE)s [Срок оценки: Up to 69.5 Months]
• Progression-Free Survival (PFS) Based on Investigator Assessment [Срок оценки: Up to Approximately 24 Months]

Вторичные конечные точки (4)

• Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment [Срок оценки: Up to Approximately 24 Months]
• Duration of Response (DoR) Based on Investigator Assessment [Срок оценки: Up to Approximately 24 Months]
• Disease Control (DC) Based on Investigator Assessment [Срок оценки: Up to Approximately 24 Months]
• OS [Срок оценки: Up to Approximately 28 Months]

Критерии участия

Критерии включения

• Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
• Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.

Критерии исключения

• Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).
• Known active/symptomatic central nervous system (CNS) metastases should be excluded.
• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded.
• Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• Yale University School of Medicine /ID# 278181 — New Haven
• Ocala Oncology Center /ID# 278269 — Ocala
• Moffitt Cancer Center /ID# 277573 — Tampa
• Fort Wayne Medical Oncology And Hematology /ID# 277336 — Fort Wayne
• Baptist Health Lexington /ID# 277729 — Lexington
• Dana-Farber Cancer Institute /ID# 277732 — Boston
• Missouri Cancer Associates /ID# 278299 — Columbia
• University Hospitals Cleveland Medical Center /ID# 277556 — Cleveland
• … и ещё 2 центра

Китай · 7 центров

• Cancer Hospital - Chinese Academy of Medical Sciences /ID# 277167 — Пекин
• Henan Cancer Hospital /ID# 277059 — Чжэнчжоу
• Union Hospital Tongji Medical College /ID# 277912 — Ухань
• The First affiliated hospital of Nanchang University /ID# 277247 — Nanchang
• Shanghai East Hospital /ID# 277111 — Шанхай
• Shanghai Pulmonary Hospital /ID# 276960 — Шанхай
• West China Hospital of Sichuan University /ID# 277852 — Чэнду

South Korea · 6 центров

• National Cancer Center /ID# 277434 — Goyang-si
• Chungbuk National University Hospital /ID# 277429 — Cheongju-si
• Seoul National University Hospital /ID# 277271 — Seoul
• Yonsei University Health System Severance Hospital /ID# 277597 — Seoul
• Asan Medical Center /ID# 277603 — Seoul
• Samsung Medical Center /ID# 277615 — Seoul

Израиль · 5 центров

• Meir Medical Center /ID# 277292 — Kefar Sava
• Assuta Ashdod Medical Center /ID# 276661 — Ashdod
• The Chaim Sheba Medical Center /ID# 276660 — Ramat Gan
• Rambam Health Care Campus- Haifa /ID# 276663 — Haifa
• Hadassah Medical Center-Hebrew University /ID# 276662 — Jerusalem

Япония · 5 центров

• National Cancer Center Hospital East /ID# 277239 — Kashiwa-shi
• Shizuoka Cancer Center /ID# 277243 — Sunto-gun
• Tokyo Metropolitan Komagome Hospital /ID# 277335 — Bunkyo Ku
• National Cancer Center Hospital /ID# 277237 — Chuo-Ku
• Wakayama Medical University Hospital /ID# 277260 — Wakayama

Сербия · 5 центров

• University Clinical Center Serbia /ID# 277007 — Belgrade
• Clinical Hospital Center - Bezanijska Kosa /ID# 277013 — Belgrade
• University Clinical Center Nis /ID# 277180 — Niš
• Institute For Pulmonary Diseases Of Vojvodina /ID# 277003 — Kamenitz
• University Clinical Center Kragujevac /ID# 277179 — Kragujevac

Испания · 5 центров

• Hospital Regional Universitario de Malaga /ID# 276927 — Málaga
• Complejo Hospitalario Universitario A Coruna /ID# 276922 — A Coruña
• Hospital Clinic de Barcelona /ID# 276878 — Barcelona
• Hospital General Universitario Gregorio Maranon /ID# 276877 — Madrid
• Hospital Universitario 12 de Octubre /ID# 277251 — Madrid

Тайвань · 5 центров

• Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267 — Kaohsiung City
• Kaohsiung Chang Gung Memorial Hospital /ID# 277725 — Kaohsiung City
• Chung Shan Medical University Hospital /ID# 277660 — Taichung
• Taipei Veterans General Hospital /ID# 277263 — Taipei
• Linkou Chang Gung Memorial Hospital /ID# 277264 — Taoyuan City

Бельгия · 4 центра

• Grand Hopital de Charleroi - Les Viviers /ID# 276897 — Charleroi
• Groupe Sante CHC - Clinique du MontLegia /ID# 276783 — Liège
• Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781 — Hasselt
• AZ Maria Middelares /ID# 277027 — Ghent

Германия · 3 центра

• Lungenfachklinik Immenhausen /ID# 278005 — Immenhausen
• Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466 — Marburg
• Evangelische Lungenklinik Berlin /ID# 277094 — Berlin

Польша · 3 центра

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 2769 — Poznan
• Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910 — Lublin
• Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 2771 — Warsaw

Turkey (Türkiye) · 3 центра

• Gazi University Medical Faculty /ID# 276843 — Ankara
• Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076 — Ankara
• Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276839 — Istanbul

Италия · 1 центр

• Fondazione Policlinico Universitario Campus Bio-Medico /ID# 277744 — Roma

Идентификаторы

NCT: NCT07155174 · M24-633 · 2024-517490-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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