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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
AbbVie
Study ID
NCT07155174
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-706 — DRUG
    Intravenous (IV) Infusion
  • Atezolizumab — DRUG
    IV Infusion
  • Etoposide — DRUG
    IV Infusion
  • Carboplatin — DRUG
    IV Injection
  • Carboplatin — DRUG
    IV Infusion
  • Lurbinectedin — DRUG
    IV Infusion

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Sep 30, 2031

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants with Adverse Events (AE)s [ Time Frame: Up to 69.5 Months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Yale University School of Medicine /ID# 278181New HavenConnecticut06510-
Ocala Oncology Center /ID# 278269OcalaFlorida34474-
Moffitt Cancer Center /ID# 277573TampaFlorida33612-
Fort Wayne Medical Oncology And Hematology /ID# 277336Fort WayneIndiana46804-
Baptist Health Lexington /ID# 277729LexingtonKentucky40503-
Dana-Farber Cancer Institute /ID# 277732BostonMassachusetts02215-
University Hospitals Cleveland Medical Center /ID# 277556ClevelandOhio44106-
The University of Texas MD Anderson Cancer Center /ID# 277929HoustonTexas77030-
Virginia Cancer Specialists - Fairfax /ID# 278298FairfaxVirginia22031-

Find similar trials in New Haven, CT

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By specialty
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By research site
Yale University School of Medicine· New Haven, CTOcala Oncology Center· Ocala, FLMoffitt Cancer Center· Tampa, FLFort Wayne Medical Oncology And Hematology· Fort Wayne, INBaptist Health Lexington· Lexington, KYDana-Farber Cancer Institute· Boston, MA

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