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
NCT ID: NCT07155174
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
180 participants
INTERVENTIONAL
2025-12-06
2031-09-30
Brief Summary
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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 expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Expansion: SOC
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Atezolizumab
IV Infusion
Etoposide
IV Infusion
Carboplatin
IV Injection
Carboplatin
IV Infusion
Lurbinectedin
IV Infusion
Expansion: ABBV-706 Dose A
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
ABBV-706
Intravenous (IV) Infusion
Atezolizumab
IV Infusion
Expansion: ABBV-706 Dose B
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
ABBV-706
Intravenous (IV) Infusion
Atezolizumab
IV Infusion
Safety Lead-In: ABBV-706 Dose A
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
ABBV-706
Intravenous (IV) Infusion
Atezolizumab
IV Infusion
Safety Lead-In: ABBV-706 Dose B
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
ABBV-706
Intravenous (IV) Infusion
Atezolizumab
IV Infusion
Safety Lead-In: Stand of Care (SOC)
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Atezolizumab
IV Infusion
Etoposide
IV Infusion
Carboplatin
IV Injection
Carboplatin
IV Infusion
Lurbinectedin
IV Infusion
Interventions
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ABBV-706
Intravenous (IV) Infusion
Atezolizumab
IV Infusion
Etoposide
IV Infusion
Carboplatin
IV Injection
Carboplatin
IV Infusion
Lurbinectedin
IV Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Central Contacts
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Related Links
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Other Identifiers
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2024-517490-24
Identifier Type: OTHER
Identifier Source: secondary_id
M24-633
Identifier Type: -
Identifier Source: org_study_id