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
Start Date
11/25/2025
Completion Date
9/1/2031
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABBV-706
Atezolizumab
Etoposide
Carboplatin
Carboplatin
Lurbinectedin
Conditions
Locations
Yale University School of Medicine /ID# 278181
New Haven, Connecticut 06510
United States
Ocala Oncology Center /ID# 278269
Ocala, Florida 34474
United States
Moffitt Cancer Center /ID# 277573
Tampa, Florida 33612
United States
Fort Wayne Medical Oncology And Hematology /ID# 277336
Fort Wayne, Indiana 46804
United States
Baptist Health Lexington /ID# 277729
Lexington, Kentucky 40503
United States
Dana-Farber Cancer Institute /ID# 277732
Boston, Massachusetts 02215
United States
Missouri Cancer Associates /ID# 278299
Columbia, Missouri 65201
United States
University Hospitals Cleveland Medical Center /ID# 277556
Cleveland, Ohio 44106
United States
The University of Texas MD Anderson Cancer Center /ID# 277929
Houston, Texas 77030
United States
Virginia Cancer Specialists - Fairfax /ID# 278298
Fairfax, Virginia 22031
United States
Grand Hopital de Charleroi - Les Viviers /ID# 276897
Charleroi, Hainaut 6280
Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 276783
Liège, Liege 4000
Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781
Hasselt, Limburg 3500
Belgium
AZ Maria Middelares /ID# 277027
Ghent, Oost-Vlaanderen 9000
Belgium
Cancer Hospital - Chinese Academy of Medical Sciences /ID# 277167
Beijing, Beijing Municipality 100021
China
Henan Cancer Hospital /ID# 277059
Zhengzhou, Henan 450008
China
Union Hospital Tongji Medical College /ID# 277912
Wuhan, Hubei 430048
China
The First affiliated hospital of Nanchang University - Nanchang /ID# 277247
Nanchang, Jiangxi 330006
China
Shanghai East Hospital /ID# 277111
Shanghai, Shanghai Municipality 200120
China
Shanghai Pulmonary Hospital /ID# 276960
Shanghai, Shanghai Municipality 200433
China
West China Hospital of Sichuan University /ID# 277852
Chengdu, Sichuan 610041
China
Lungenfachklinik Immenhausen /ID# 278005
Immenhausen, Hesse 34376
Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466
Marburg, Hesse 35043
Germany
Evangelische Lungenklinik Berlin /ID# 277094
Berlin, 13125
Germany
Meir Medical Center /ID# 277292
Kefar Sava, Central District 4428164
Israel
Assuta Ashdod Medical Center /ID# 276661
Ashdod, Southern District 7747600
Israel
The Chaim Sheba Medical Center /ID# 276660
Ramat Gan, Tel Aviv 5265601
Israel
Rambam Health Care Campus- Haifa /ID# 276663
Haifa, 3109601
Israel
Hadassah Medical Center-Hebrew University /ID# 276662
Jerusalem, 91120
Israel
National Cancer Center Hospital East /ID# 277239
Kashiwa-shi, Chiba 277-8577
Japan
Shizuoka Cancer Center /ID# 277243
Sunto-gun, Shizuoka 411-8777
Japan
Tokyo Metropolitan Komagome Hospital /ID# 277335
Bunkyo Ku, Tokyo 113-8677
Japan
National Cancer Center Hospital /ID# 277237
Chuo-Ku, Tokyo 104-0045
Japan
Wakayama Medical University Hospital /ID# 277260
Wakayama, Wakayama 641-8510
Japan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 276907
Poznan, Greater Poland Voivodeship 60-569
Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910
Lublin, Lublin Voivodeship 20-090
Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 277112
Warsaw, Masovian Voivodeship 02-781
Poland
University Clinical Center Serbia /ID# 277007
Belgrade, Beograd 11000
Serbia
Clinical Hospital Center - Bezanijska Kosa /ID# 277013
Belgrade, Beograd 11080
Serbia
University Clinical Center Nis /ID# 277180
Niš, Nisavski Okrug 18300
Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277003
Kamenitz, Sremski Okrug 21208
Serbia
University Clinical Center Kragujevac /ID# 277179
Kragujevac, Sumadijski Okrug 34000
Serbia
National Cancer Center /ID# 277434
Goyang-si, Gyeonggido 10408
South Korea
Chungbuk National University Hospital /ID# 277429
Cheongju-si, North Chungcheong 28644
South Korea
Seoul National University Hospital /ID# 277271
Seoul, Seoul Teugbyeolsi 03080
South Korea
Yonsei University Health System Severance Hospital /ID# 277597
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 277603
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 277615
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Regional Universitario de Malaga /ID# 276927
Málaga, Andalusia 29010
Spain
Complejo Hospitalario Universitario A Coruna /ID# 276922
A Coruña, 15006
Spain
Hospital Clinic de Barcelona /ID# 276878
Barcelona, 08036
Spain
Hospital General Universitario Gregorio Maranon /ID# 276877
Madrid, 28007
Spain
Hospital Universitario 12 de Octubre /ID# 277251
Madrid, 28041
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267
Kaohsiung City, 807
Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277725
Kaohsiung City, 833
Taiwan
Chung Shan Medical University Hospital /ID# 277660
Taichung, 402
Taiwan
Taipei Veterans General Hospital /ID# 277263
Taipei, 112
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277264
Taoyuan City, 333
Taiwan
Gazi University Medical Faculty /ID# 276843
Ankara, 06560
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076
Ankara, 06620
Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276839
Istanbul, 34722
Turkey (Türkiye)