Skip to main content
Back to Trials
NCT07365241PHASE3Recruiting

A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer

AbbVie

Start Date

7/2/2026

Completion Date

9/1/2030

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, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide. Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC \[topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)\]. The estimated duration of the study is approximately 53 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 Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC). * Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as: * In the 1L and 2L setting respectively, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI, if eligible for CPI) and 2L tarlatamab; or * In the 1L and 2L setting, platinum-based chemotherapy (i.e., carboplatin and etoposide with atezolizumab and lurbinectedin in combination with atezolizumab maintenance and 2L tarlatamab; or * In the 1L setting, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI if eligible) in combination with tarlatamab in frontline induction and/or maintenance * Participants must be considered suitable to receive SOC comparator (topotecan, lurbinectedin, or amrubicin). * Participants must 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. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Participants with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are: * Previously treated and not requiring anticonvulsants and steroids for at least 7 days prior to first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone dose of ≤ 10 mg/day are eligible or; * Untreated and asymptomatic not requiring anticonvulsants and steroids for at least 7 days prior to the first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone of ≤ 10 mg/day are eligible. Exclusion Criteria: * Participants with known active/symptomatic central nervous system metastases. * Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan. * Participants with any clinically significant conditions that would adversely affect the participation in the study, and the subject should have a life expectancy of at least 3 months. * Participants who have received prior treatment with a seizure-related 6 homolog (SEZ6) targeted Antibody drug conjugate (ADC), other targeted ADCs, or any other investigational agent not including tarlatamab in 1L. * Participants who have received prior treatment with any Top1i such as topotecan, irinotecan, belotecan, camptothecin, rubitecan, exatecan or locally approved topoisomerase I inhibitor (Top1i) payload.

Interventions

DRUG

ABBV-706

DRUG

Topotecan

DRUG

Topotecan

DRUG

Lurbinectedin

DRUG

Amrubicin

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Small Cell Lung Cancer

Locations

Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063

Birmingham, Alabama 35243

United States

Usa Mitchell Cancer Institute /ID# 280198

Mobile, Alabama 36604

United States

City Of Hope - Phoenix /ID# 281323

Goodyear, Arizona 85338

United States

City of Hope National Medical Center /ID# 281322

Duarte, California 91010

United States

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396

Irvine, California 92618

United States

Florida Cancer Specialists & Research Institute - South /ID# 281387

Fort Myers, Florida 33901

United States

Orlando Health Cancer Institute /ID# 280418

Orlando, Florida 32806

United States

Moffitt Cancer Center /ID# 279732

Tampa, Florida 33612

United States

City Of Hope - Atlanta /ID# 279929

Newnan, Georgia 30265

United States

University of Chicago Medical Center /ID# 280149

Chicago, Illinois 60637

United States

OSF St. Francis Medical Center /ID# 279930

Peoria, Illinois 61637-0001

United States

Springfield Clinic - First /ID# 281309

Springfield, Illinois 62702

United States

City Of Hope - Chicago /ID# 281335

Zion, Illinois 60099

United States

Franciscan St. Francis Health /ID# 279788

Indianapolis, Indiana 46237

United States

Baptist Health Louisville /ID# 280025

Louisville, Kentucky 40207

United States

Dana-Farber Cancer Institute /ID# 279690

Boston, Massachusetts 02215

United States

Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955

Grand Rapids, Michigan 49503

United States

Minnesota Oncology - Edina Clinic /ID# 280698

Edina, Minnesota 55435

United States

Mayo Clinic Hospital Rochester /ID# 279784

Rochester, Minnesota 55905

United States

Inspira Medical Center Mullica Hill /ID# 280574

Mullica Hill, New Jersey 08062

United States

FirstHealth of the Carolinas- Speciality Center /ID# 279857

Pinehurst, North Carolina 28374

United States

Oncology Hematology Care - Fairfield /ID# 280641

Fairfield, Ohio 45014

United States

Willamette Valley Cancer Institute and Research Center /ID# 280617

Eugene, Oregon 97401

United States

Oregon Health and Science University /ID# 280071

Portland, Oregon 97239

United States

St. Lukes University Hospital /ID# 280204

Bethlehem, Pennsylvania 18015

United States

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 280619

Knoxville, Tennessee 37909

United States

University Of Tennessee Medical Center /ID# 279896

Knoxville, Tennessee 37920

United States

Baptist Memorial Hospital /ID# 281405

Memphis, Tennessee 38120

United States

SCRI Oncology Partners /ID# 279779

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center /ID# 280169

Nashville, Tennessee 37232

United States

The University of Texas MD Anderson Cancer Center /ID# 280070

Houston, Texas 77030

United States

Texas Oncology - Northeast Texas /ID# 280642

Tyler, Texas 75702

United States

Blue Ridge Cancer Care - Blacksburg /ID# 281583

Blacksburg, Virginia 24060

United States

Virginia Cancer Specialists - Fairfax /ID# 280710

Fairfax, Virginia 22031

United States

Shenandoah Oncology /ID# 280699

Winchester, Virginia 22601

United States

West Virginia University Hospitals /ID# 279883

Morgantown, West Virginia 26506

United States

University of Wisconsin /ID# 279909

Madison, Wisconsin 53792-0001

United States

Universitaetsklinikum Krems /ID# 280608

Krems, Lower Austria 3500

Austria

Ordensklinikum Linz Elisabethinen /ID# 281314

Linz, Upper Austria 4010

Austria

AZ-Delta. /ID# 280341

Roeselare, West-Vlaanderen 8800

Belgium

Hospital Sirio Libanes - Sao Paulo /ID# 279948

São Paulo, 01308-050

Brazil

Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 280600

Marseille, Bouches-du-Rhone 13915

France

Universtaetsklinikum Wuerzburg /ID# 280834

Würzburg, Bavaria 97078

Germany

Klinikum Kassel /ID# 280427

Kassel, Hesse 34125

Germany

Universitaetsklinikum Koeln /ID# 280867

Cologne, North Rhine-Westphalia 50937

Germany

Klinikum Koeln-Merheim /ID# 280958

Cologne, North Rhine-Westphalia 51109

Germany

Henry Dunnant Hospital Center /ID# 280369

Athens, Attica 11526

Greece

Metropolitan Hospital /ID# 280359

Piraeus, Attica 18547

Greece

Interbalkan Medical Center Of Thessaloniki /ID# 280361

Thessaloniki, 57001

Greece

Fujita Health University Hospital /ID# 279969

Toyoake, Aichi-ken 470-1192

Japan

Hirosaki University Hospital /ID# 279926

Hirosaki, Aomori 036-8563

Japan

Kyushu University Hospital /ID# 279964

Fukuoka, Fukuoka 812-8582

Japan

Hokkaido Cancer Center /ID# 280024

Sapporo, Hokkaido 003-0804

Japan

Kobe University Hospital /ID# 280290

Kobe, Hyōgo 650-0017

Japan

Kitasato University Hospital /ID# 280033

Sagamihara-shi, Kanagawa 252-0375

Japan

Sendai Kousei Hospital /ID# 279790

Sendai, Miyagi 981-0914

Japan

Niigata University Medical and Dental Hospital /ID# 280027

Niigata, Niigata 951-8520

Japan

Okayama University Hospital /ID# 280023

Okayama, Okayama-ken 700-8558

Japan

Kansai Medical University Hospital /ID# 279925

Hirakata-shi, Osaka 573-1191

Japan

Osaka International Cancer Institute /ID# 280026

Osaka, Osaka 5418567

Japan

Kindai University Hospital /ID# 280034

Sakai-shi, Osaka 590-0197

Japan

Saitama Medical University International Medical Center /ID# 279962

Hidaka, Saitama 350-1298

Japan

Shizuoka Cancer Center /ID# 279924

Sunto-gun, Shizuoka 411-8777

Japan

Juntendo University Hospital /ID# 280095

Bunkyo-ku, Tokyo 113-8431

Japan

Nippon Medical School Hospital /ID# 280687

Bunkyo-ku, Tokyo 113-8603

Japan

Teikyo University Hospital /ID# 280307

Tokyo, 173-8605

Japan

Hospital Clinic de Barcelona /ID# 281271

Barcelona, 08036

Spain

Hospital Universitario Ramon y Cajal /ID# 280888

Madrid, 28034

Spain

University Hospital Basel /ID# 280787

Basel Town, Canton of Basel-City 4031

Switzerland

Hopitaux Universitaires de Geneve /ID# 280748

Geneva, Canton of Geneva 1205

Switzerland

Centre Hospitalier Universitaire Vaudois /ID# 280847

Lausanne, Canton of Vaud 1011

Switzerland

EOC Ospedale Regionale Lugano /ID# 280583

Lugano, Canton Ticino 6900

Switzerland