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

Recruiting now · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07155174

Run by

AbbVie

People needed

180

Starts

2025-11-25

Expected to finish

2031-09-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dana-Farber Cancer Institute /ID# 277732 — Boston, Massachusetts, United States (enrolling)
• Missouri Cancer Associates /ID# 278299 — Columbia, Missouri, United States (enrolling)
• University Hospitals Cleveland Medical Center /ID# 277556 — Cleveland, Ohio, United States (enrolling)
• The University of Texas MD Anderson Cancer Center /ID# 277929 — Houston, Texas, United States (enrolling)
• Virginia Cancer Specialists - Fairfax /ID# 278298 — Fairfax, Virginia, United States (enrolling)
• Grand Hopital de Charleroi - Les Viviers /ID# 276897 — Charleroi, Hainaut, Belgium (enrolling)
• Groupe Sante CHC - Clinique du MontLegia /ID# 276783 — Liège, Liege, Belgium (enrolling)
• Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781 — Hasselt, Limburg, Belgium (enrolling)
• AZ Maria Middelares /ID# 277027 — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• Cancer Hospital - Chinese Academy of Medical Sciences /ID# 277167 — Beijing, Beijing Municipality, China (enrolling)
• Henan Cancer Hospital /ID# 277059 — Zhengzhou, Henan, China (enrolling)
• Union Hospital Tongji Medical College /ID# 277912 — Wuhan, Hubei, China (enrolling)
• The First affiliated hospital of Nanchang University /ID# 277247 — Nanchang, Jiangxi, China (enrolling)
• Shanghai East Hospital /ID# 277111 — Shanghai, Shanghai Municipality, China (enrolling)
• Shanghai Pulmonary Hospital /ID# 276960 — Shanghai, Shanghai Municipality, China (enrolling)
• West China Hospital of Sichuan University /ID# 277852 — Chengdu, Sichuan, China (enrolling)
• Lungenfachklinik Immenhausen /ID# 278005 — Immenhausen, Hesse, Germany (enrolling)
• Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466 — Marburg, Hesse, Germany (enrolling)
• Evangelische Lungenklinik Berlin /ID# 277094 — Berlin, Germany (enrolling)
• Meir Medical Center /ID# 277292 — Kefar Sava, Central District, Israel (enrolling)
• Assuta Ashdod Medical Center /ID# 276661 — Ashdod, Southern District, Israel (enrolling)
• The Chaim Sheba Medical Center /ID# 276660 — Ramat Gan, Tel Aviv, Israel (enrolling)
• Rambam Health Care Campus- Haifa /ID# 276663 — Haifa, Israel (enrolling)
• Hadassah Medical Center-Hebrew University /ID# 276662 — Jerusalem, Israel (enrolling)
• Baptist Health Lexington /ID# 277729 — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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