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
Recruiting · NCT07365241 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 19 US states.
- 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
- St. Lukes University Hospital /ID# 280204 - Bethlehem, Pennsylvania, 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
- Virginia Cancer Specialists - Fairfax /ID# 280710 - Fairfax, 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
- Hospital Clinic de Barcelona /ID# 281271 - Barcelona, Spain
- Interbalkan Medical Center Of Thessaloniki /ID# 280361 - Thessaloniki, Greece
- Teikyo University Hospital /ID# 280307 - Tokyo, Japan
- Fujita Health University Hospital /ID# 279969 - Toyoake, Aichi-ken, Japan
- Hirosaki University Hospital /ID# 279926 - Hirosaki, Aomori, Japan
- Henry Dunnant Hospital Center /ID# 280369 - Athens, Attica, Greece
- Metropolitan Hospital /ID# 280359 - Piraeus, Attica, Greece
- Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 280600 - Marseille, Bouches-du-Rhone, France
- EOC Ospedale Regionale Lugano /ID# 280583 - Lugano, Canton Ticino, Switzerland
- University Hospital Basel /ID# 280787 - Basel Town, Canton of Basel-City, Switzerland
- Hopitaux Universitaires de Geneve /ID# 280748 - Geneva, Canton of Geneva, Switzerland
- Centre Hospitalier Universitaire Vaudois /ID# 280847 - Lausanne, Canton of Vaud, Switzerland
- Kyushu University Hospital /ID# 279964 - Fukuoka, Fukuoka, Japan
- Klinikum Kassel /ID# 280427 - Kassel, Hesse, Germany
- 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
- Universitaetsklinikum Krems /ID# 280608 - Krems, Lower Austria, Austria
- Sendai Kousei Hospital /ID# 279790 - Sendai, Miyagi, Japan
- Niigata University Medical and Dental Hospital /ID# 280027 - Niigata, Niigata, Japan
- Universitaetsklinikum Koeln /ID# 280867 - Cologne, North Rhine-Westphalia, Germany
- 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
Showing 60 of 63 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →