RecruitingPhase 2NCT07155174

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

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)


Sponsor

AbbVie

Enrollment

180 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ABBV-706 combined with atezolizumab (an immunotherapy) as a first-line treatment for people with extensive-stage small cell lung cancer (a fast-growing form of lung cancer that has spread beyond the chest). Researchers are looking at the best dose, safety, and effectiveness compared to standard care. **You may be eligible if...** - You have confirmed extensive-stage small cell lung cancer that has not been treated before - Your overall health is good enough for treatment (ECOG performance status 0–1) - You have measurable cancer on imaging - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have previously been treated for limited-stage small cell lung cancer - You have active or symptomatic brain metastases - You have a history of interstitial lung disease or pneumonitis that required steroid treatment - You have other serious conditions that would affect your ability to participate safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-706

Intravenous (IV) Infusion

DRUGAtezolizumab

IV Infusion

DRUGEtoposide

IV Infusion

DRUGCarboplatin

IV Injection

DRUGCarboplatin

IV Infusion

DRUGLurbinectedin

IV Infusion


Locations(28)

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

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

Groupe Sante CHC - Clinique du MontLegia /ID# 276783

Liège, Liege, Belgium

AZ Maria Middelares /ID# 277027

Ghent, Oost-Vlaanderen, Belgium

Lungenfachklinik Immenhausen /ID# 278005

Immenhausen, Hesse, Germany

Meir Medical Center /ID# 277292

Kfar Saba, 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

National Cancer Center /ID# 277434

Goyang-si, Gyeonggido, South Korea

Chungbuk National University Hospital /ID# 277429

Cheongju-si, North Chungcheong, South Korea

Complejo Hospitalario Universitario A Coruña /ID# 276922

A Coruña, A Coruna, Spain

Hospital Regional Universitario de Malaga /ID# 276927

Málaga, Andalusia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267

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

View Full Details on ClinicalTrials.gov

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NCT07155174


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