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NCT07155174PHASE2Recruiting

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

AbbVie

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

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.

Interventions

DRUG

ABBV-706

DRUG

Atezolizumab

DRUG

Etoposide

DRUG

Carboplatin

DRUG

Carboplatin

DRUG

Lurbinectedin

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Conditions

Small Cell Lung Cancer

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)