A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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, 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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Ocala Oncology Center /ID# 278269
RECRUITING
Ocala
Indiana
Fort Wayne Medical Oncology And Hematology /ID# 277336
RECRUITING
Fort Wayne
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2031-09
Participants
Target number of participants: 180
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: Expansion: SOC
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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