RecruitingRecruiting
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
NCT07155174 · AbbVie
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-25
Estimated completion: 2031-09
Last updated: 2026-05-18
Interventions
Drug: ABBV-706Drug: AtezolizumabDrug: EtoposideDrug: CarboplatinDrug: CarboplatinDrug: Lurbinectedin
Primary outcomes
- • Number of Participants with Adverse Events (AE)s (Up to 69.5 Months)
- • Progression-Free Survival (PFS) Based on Investigator Assessment (Up to Approximately 24 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (49)
Yale University School of Medicine /ID# 278181Recruiting
New Haven, Connecticut, United States
Ocala Oncology Center /ID# 278269Recruiting
Ocala, Florida, United States
Moffitt Cancer Center /ID# 277573Recruiting
Tampa, Florida, United States
Fort Wayne Medical Oncology And Hematology /ID# 277336Recruiting
Fort Wayne, Indiana, United States
Baptist Health Lexington /ID# 277729Recruiting
Lexington, Kentucky, United States
Dana-Farber Cancer Institute /ID# 277732Recruiting
Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center /ID# 277556Recruiting
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center /ID# 277929Recruiting
Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 278298Recruiting
Fairfax, Virginia, United States
Grand Hôpital de Charleroi - Les Viviers /ID# 276897Recruiting
Charleroi, Hainaut, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 276783Recruiting
Liège, Liege, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781Recruiting
Hasselt, Limburg, Belgium
AZ Maria Middelares /ID# 277027Recruiting
Ghent, Oost-Vlaanderen, Belgium
Lungenfachklinik Immenhausen /ID# 278005Recruiting
Immenhausen, Hesse, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466Recruiting
Marburg, Hesse, Germany
Evangelische Lungenklinik Berlin /ID# 277094Recruiting
Berlin, Germany
Meir Medical Center /ID# 277292Recruiting
Kefar Sava, Central District, Israel
Assuta Ashdod Medical Center /ID# 276661Recruiting
Ashdod, Southern District, Israel
The Chaim Sheba Medical Center /ID# 276660Recruiting
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 276663Recruiting
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 276662Recruiting
Jerusalem, Israel
National Cancer Center Hospital East /ID# 277239Recruiting
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center /ID# 277243Recruiting
Sunto-gun, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital /ID# 277335Recruiting
Bunkyo Ku, Tokyo, Japan
National Cancer Center Hospital /ID# 277237Recruiting
Chuo-Ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 277260Recruiting
Wakayama, Wakayama, Japan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 276907Recruiting
Poznan, Greater Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910Recruiting
Lublin, Lublin Voivodeship, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 277112Recruiting
Warsaw, Masovian Voivodeship, Poland
University Clinical Center Serbia /ID# 277007Recruiting
Belgrade, Beograd, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277013Recruiting
Belgrade, Beograd, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277003Recruiting
Kamenitz, Sremski Okrug, Serbia
University Clinical Center Kragujevac /ID# 277179Recruiting
Kragujevac, Sumadijski Okrug, Serbia
National Cancer Center /ID# 277434Recruiting
Goyang-si, Gyeonggido, South Korea
Chungbuk National University Hospital /ID# 277429Recruiting
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 277271Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 277597Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 277603Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 277615Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 276922Recruiting
A Coruña, A Coruna, Spain
Hospital Regional Universitario de Malaga /ID# 276927Recruiting
Málaga, Andalusia, Spain
Hospital Clinic de Barcelona /ID# 276878Recruiting
Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 277251Recruiting
Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267Recruiting
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277725Recruiting
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital /ID# 277660Recruiting
Taichung, Taiwan
Taipei Veterans General Hospital /ID# 277263Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277264Recruiting
Taoyuan City, Taiwan
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076Recruiting
Ankara, Turkey (Türkiye)