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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

RecruitingPhase 2Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 expans

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • ABBV-706
  • Atezolizumab
  • Etoposide
  • Carboplatin
  • Carboplatin
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Where

69 sites
Yale University School of Medicine /ID# 278181
New Haven, United States
University of Florida College of Medicine /ID# 277496
Gainesville, United States
Ocala Oncology Center /ID# 278269
Ocala, United States
Moffitt Cancer Center /ID# 277573
Tampa, United States
Fort Wayne Medical Oncology And Hematology /ID# 277336
Fort Wayne, United States
Baptist Health Lexington /ID# 277729
Lexington, United States
Dana-Farber Cancer Institute /ID# 277732
Boston, United States
Henry Ford Hospital - Detroit /ID# 277218
Detroit, United States

โ€ฆand 61 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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