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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
Sponsor: AbbVie
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-11-25
Completion Date
2031-09
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
ABBV-706
Intravenous (IV) Infusion
Atezolizumab
IV Infusion
Etoposide
IV Infusion
Carboplatin
IV Injection
Carboplatin
IV Infusion
Lurbinectedin
IV Infusion
Locations (49)
Yale University School of Medicine /ID# 278181
New Haven, Connecticut, United States
Ocala Oncology Center /ID# 278269
Ocala, Florida, United States
Moffitt Cancer Center /ID# 277573
Tampa, Florida, United States
Fort Wayne Medical Oncology And Hematology /ID# 277336
Fort Wayne, Indiana, United States
Baptist Health Lexington /ID# 277729
Lexington, Kentucky, United States
Dana-Farber Cancer Institute /ID# 277732
Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center /ID# 277556
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center /ID# 277929
Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 278298
Fairfax, Virginia, United States
Grand Hôpital de Charleroi - Les Viviers /ID# 276897
Charleroi, Hainaut, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 276783
Liège, Liege, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781
Hasselt, Limburg, Belgium
AZ Maria Middelares /ID# 277027
Ghent, Oost-Vlaanderen, Belgium
Lungenfachklinik Immenhausen /ID# 278005
Immenhausen, Hesse, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466
Marburg, Hesse, Germany
Evangelische Lungenklinik Berlin /ID# 277094
Berlin, Germany
Meir Medical Center /ID# 277292
Kefar Sava, Central District, Israel
Assuta Ashdod Medical Center /ID# 276661
Ashdod, Southern District, Israel
The Chaim Sheba Medical Center /ID# 276660
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 276663
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 276662
Jerusalem, Israel
National Cancer Center Hospital East /ID# 277239
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center /ID# 277243
Sunto-gun, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital /ID# 277335
Bunkyo Ku, Tokyo, Japan
National Cancer Center Hospital /ID# 277237
Chuo-Ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 277260
Wakayama, Wakayama, Japan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 276907
Poznan, Greater Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910
Lublin, Lublin Voivodeship, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 277112
Warsaw, Masovian Voivodeship, Poland
University Clinical Center Serbia /ID# 277007
Belgrade, Beograd, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277013
Belgrade, Beograd, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277003
Kamenitz, Sremski Okrug, Serbia
University Clinical Center Kragujevac /ID# 277179
Kragujevac, Sumadijski Okrug, Serbia
National Cancer Center /ID# 277434
Goyang-si, Gyeonggido, South Korea
Chungbuk National University Hospital /ID# 277429
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 277271
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 277597
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 277603
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 277615
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 276922
A Coruña, A Coruna, Spain
Hospital Regional Universitario de Malaga /ID# 276927
Málaga, Andalusia, Spain
Hospital Clinic de Barcelona /ID# 276878
Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 277251
Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277725
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital /ID# 277660
Taichung, Taiwan
Taipei Veterans General Hospital /ID# 277263
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277264
Taoyuan City, Taiwan
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076
Ankara, Turkey (Türkiye)