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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
NCT07365241 · AbbVie
In plain English
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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)
About this study
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
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.
Study design
Enrollment target: 531 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-02
Estimated completion: 2030-09
Last updated: 2026-09-15
Interventions
Drug: ABBV-706Drug: TopotecanDrug: TopotecanDrug: LurbinectedinDrug: Amrubicin
Primary outcomes
- • Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) (Up to approximately 24 months)
- • Overall Survival (OS) (Up to approximately 28 months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (63)
Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063Recruiting
Birmingham, Alabama, United States
Usa Mitchell Cancer Institute /ID# 280198Recruiting
Mobile, Alabama, United States
City Of Hope - Phoenix /ID# 281323Recruiting
Goodyear, Arizona, United States
City of Hope National Medical Center /ID# 281322Recruiting
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396Recruiting
Irvine, California, United States
Florida Cancer Specialists & Research Institute - South /ID# 281387Recruiting
Fort Myers, Florida, United States
Orlando Health Cancer Institute /ID# 280418Recruiting
Orlando, Florida, United States
Moffitt Cancer Center /ID# 279732Recruiting
Tampa, Florida, United States
City Of Hope - Atlanta /ID# 279929Recruiting
Newnan, Georgia, United States
OSF St. Francis Medical Center /ID# 279930Recruiting
Peoria, Illinois, United States
Springfield Clinic - First /ID# 281309Recruiting
Springfield, Illinois, United States
City Of Hope - Chicago /ID# 281335Recruiting
Zion, Illinois, United States
Franciscan St. Francis Health /ID# 279788Recruiting
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute /ID# 279690Recruiting
Boston, Massachusetts, United States
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955Recruiting
Grand Rapids, Michigan, United States
Minnesota Oncology - Edina Clinic /ID# 280698Recruiting
Edina, Minnesota, United States
FirstHealth of the Carolinas- Speciality Center /ID# 279857Recruiting
Pinehurst, North Carolina, United States
Oncology Hematology Care - Fairfield /ID# 280641Recruiting
Fairfield, Ohio, United States
Willamette Valley Cancer Institute and Research Center /ID# 280617Recruiting
Eugene, Oregon, United States
St. Lukes University Hospital /ID# 280204Recruiting
Bethlehem, Pennsylvania, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 280619Recruiting
Knoxville, Tennessee, United States
University Of Tennessee Medical Center /ID# 279896Recruiting
Knoxville, Tennessee, United States
Baptist Memorial Hospital /ID# 281405Recruiting
Memphis, Tennessee, United States
SCRI Oncology Partners /ID# 279779Recruiting
Nashville, Tennessee, United States
Vanderbilt University Medical Center /ID# 280169Recruiting
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center /ID# 280070Recruiting
Houston, Texas, United States
Texas Oncology - Northeast Texas /ID# 280642Recruiting
Tyler, Texas, United States
Blue Ridge Cancer Care - Blacksburg /ID# 281583Recruiting
Blacksburg, Virginia, United States
Virginia Cancer Specialists - Fairfax /ID# 280710Recruiting
Fairfax, Virginia, United States
Shenandoah Oncology /ID# 280699Recruiting
Winchester, Virginia, United States
West Virginia University Hospitals /ID# 279883Recruiting
Morgantown, West Virginia, United States
University of Wisconsin /ID# 279909Recruiting
Madison, Wisconsin, United States
Universitaetsklinikum Krems /ID# 280608Recruiting
Krems, Lower Austria, Austria
Ordensklinikum Linz Elisabethinen /ID# 281314Recruiting
Linz, Upper Austria, Austria
AZ-Delta. /ID# 280341Recruiting
Roeselare, West-Vlaanderen, Belgium
Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 280600Recruiting
Marseille, Bouches-du-Rhone, France
Klinikum Kassel /ID# 280427Recruiting
Kassel, Hesse, Germany
Universitaetsklinikum Koeln /ID# 280867Recruiting
Cologne, North Rhine-Westphalia, Germany
Henry Dunnant Hospital Center /ID# 280369Recruiting
Athens, Attica, Greece
Metropolitan Hospital /ID# 280359Recruiting
Piraeus, Attica, Greece
Interbalkan Medical Center Of Thessaloniki /ID# 280361Recruiting
Thessaloniki, Greece
Fujita Health University Hospital /ID# 279969Recruiting
Toyoake, Aichi-ken, Japan
Hirosaki University Hospital /ID# 279926Recruiting
Hirosaki, Aomori, Japan
Kyushu University Hospital /ID# 279964Recruiting
Fukuoka, Fukuoka, Japan
Hokkaido Cancer Center /ID# 280024Recruiting
Sapporo, Hokkaido, Japan
Kobe University Hospital /ID# 280290Recruiting
Kobe, Hyōgo, Japan
Kitasato University Hospital /ID# 280033Recruiting
Sagamihara-shi, Kanagawa, Japan
Sendai Kousei Hospital /ID# 279790Recruiting
Sendai, Miyagi, Japan
Niigata University Medical and Dental Hospital /ID# 280027Recruiting
Niigata, Niigata, Japan
Okayama University Hospital /ID# 280023Recruiting
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital /ID# 279925Recruiting
Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute /ID# 280026Recruiting
Osaka, Osaka, Japan
Kindai University Hospital /ID# 280034Recruiting
Sakai-shi, Osaka, Japan
Saitama Medical University International Medical Center /ID# 279962Recruiting
Hidaka, Saitama, Japan
Shizuoka Cancer Center /ID# 279924Recruiting
Sunto-gun, Shizuoka, Japan
Juntendo University Hospital /ID# 280095Recruiting
Bunkyo-ku, Tokyo, Japan
Nippon Medical School Hospital /ID# 280687Recruiting
Bunkyo-ku, Tokyo, Japan
Teikyo University Hospital /ID# 280307Recruiting
Tokyo, Japan
Hospital Clinic de Barcelona /ID# 281271Recruiting
Barcelona, Spain
University Hospital Basel /ID# 280787Recruiting
Basel Town, Canton of Basel-City, Switzerland
Hopitaux Universitaires de Geneve /ID# 280748Recruiting
Geneva, Canton of Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois /ID# 280847Recruiting
Lausanne, Canton of Vaud, Switzerland
EOC Ospedale Regionale Lugano /ID# 280583Recruiting
Lugano, Canton Ticino, Switzerland