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RECRUITING

NCT07365241

PHASE3

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

531

Start Date

2026-07-02

Completion Date

2030-09

Last Updated

2026-08-28

Healthy Volunteers

Conditions

Small Cell Lung Cancer

Interventions

DRUG

ABBV-706

Intravenous (IV) Infusion

DRUG

Topotecan

IV Infusion

DRUG

Topotecan

Oral

DRUG

Lurbinectedin

IV Infusion

DRUG

Amrubicin

IV Infusion

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.

Locations (56)

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

Birmingham, Alabama, United States

Usa Mitchell Cancer Institute /ID# 280198

Mobile, Alabama, United States

City Of Hope - Phoenix /ID# 281323

Goodyear, Arizona, United States

City of Hope National Medical Center /ID# 281322

Duarte, California, United States

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

Irvine, California, United States

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

Fort Myers, Florida, United States

Orlando Health Cancer Institute /ID# 280418

Orlando, Florida, United States

Moffitt Cancer Center /ID# 279732

Tampa, Florida, United States

City Of Hope - Atlanta /ID# 279929

Newnan, Georgia, United States

OSF St. Francis Medical Center /ID# 279930

Peoria, Illinois, United States

Springfield Clinic - First /ID# 281309

Springfield, Illinois, United States

City Of Hope - Chicago /ID# 281335

Zion, Illinois, United States

Franciscan St. Francis Health /ID# 279788

Indianapolis, Indiana, United States

Dana-Farber Cancer Institute /ID# 279690

Boston, Massachusetts, United States

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

Grand Rapids, Michigan, United States

Minnesota Oncology - Edina Clinic /ID# 280698

Edina, Minnesota, United States

FirstHealth of the Carolinas- Speciality Center /ID# 279857

Pinehurst, North Carolina, United States

Oncology Hematology Care - Fairfield /ID# 280641

Fairfield, Ohio, United States

Willamette Valley Cancer Institute and Research Center /ID# 280617

Eugene, Oregon, United States

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

Knoxville, Tennessee, United States

University Of Tennessee Medical Center /ID# 279896

Knoxville, Tennessee, United States

Baptist Memorial Hospital /ID# 281405

Memphis, Tennessee, United States

SCRI Oncology Partners /ID# 279779

Nashville, Tennessee, United States

Vanderbilt University Medical Center /ID# 280169

Nashville, Tennessee, United States

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

Houston, Texas, United States

Texas Oncology - Northeast Texas /ID# 280642

Tyler, Texas, United States

Blue Ridge Cancer Care - Blacksburg /ID# 281583

Blacksburg, Virginia, United States

Shenandoah Oncology /ID# 280699

Winchester, Virginia, United States

West Virginia University Hospitals /ID# 279883

Morgantown, West Virginia, United States

University of Wisconsin /ID# 279909

Madison, Wisconsin, United States

Ordensklinikum Linz Elisabethinen /ID# 281314

Linz, Upper Austria, Austria

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

Marseille, Bouches-du-Rhone, France

Klinikum Kassel /ID# 280427

Kassel, Hesse, Germany

Universitaetsklinikum Koeln /ID# 280867

Cologne, North Rhine-Westphalia, Germany

Metropolitan Hospital /ID# 280359

Piraeus, Attica, Greece

Fujita Health University Hospital /ID# 279969

Toyoake, Aichi-ken, Japan

Hirosaki University Hospital /ID# 279926

Hirosaki, Aomori, Japan

Kyushu University Hospital /ID# 279964

Fukuoka, Fukuoka, Japan

Hokkaido Cancer Center /ID# 280024

Sapporo, Hokkaido, Japan

Kobe University Hospital /ID# 280290

Kobe, Hyōgo, Japan

Kitasato University Hospital /ID# 280033

Sagamihara-shi, Kanagawa, Japan

Sendai Kousei Hospital /ID# 279790

Sendai, Miyagi, Japan

Niigata University Medical and Dental Hospital /ID# 280027

Niigata, Niigata, Japan

Okayama University Hospital /ID# 280023

Okayama, Okayama-ken, Japan

Kansai Medical University Hospital /ID# 279925

Hirakata-shi, Osaka, Japan

Osaka International Cancer Institute /ID# 280026

Osaka, Osaka, Japan

Kindai University Hospital /ID# 280034

Sakai-shi, Osaka, Japan

Saitama Medical University International Medical Center /ID# 279962

Hidaka, Saitama, Japan

Shizuoka Cancer Center /ID# 279924

Sunto-gun, Shizuoka, Japan

Juntendo University Hospital /ID# 280095

Bunkyo-ku, Tokyo, Japan

Nippon Medical School Hospital /ID# 280687

Bunkyo-ku, Tokyo, Japan

Teikyo University Hospital /ID# 280307

Tokyo, Japan

Hospital Clinic de Barcelona /ID# 281271

Barcelona, Spain

Hopitaux Universitaires de Geneve /ID# 280748

Geneva, Canton of Geneva, Switzerland

Centre Hospitalier Universitaire Vaudois /ID# 280847

Lausanne, Canton of Vaud, Switzerland

EOC Ospedale Regionale Lugano /ID# 280583

Lugano, Canton Ticino, Switzerland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)