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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: ABBV-706
    Intravenous (IV) Infusion
  • Drug: Atezolizumab
    IV Infusion
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.
  • Drug: ABBV-706
    Intravenous (IV) Infusion
  • Drug: Atezolizumab
    IV Infusion
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.
  • Drug: Atezolizumab
    IV Infusion
  • Drug: Etoposide
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
  • Drug: Lurbinectedin
    IV Infusion
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.
  • Drug: ABBV-706
    Intravenous (IV) Infusion
  • Drug: Atezolizumab
    IV Infusion
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.
  • Drug: ABBV-706
    Intravenous (IV) Infusion
  • Drug: Atezolizumab
    IV Infusion
Experimental
Expansion: SOC 		Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
  • Drug: Atezolizumab
    IV Infusion
  • Drug: Etoposide
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
  • Drug: Lurbinectedin
    IV Infusion

Recruiting Locations

Ocala Oncology Center /ID# 278269
Ocala 4166673, Florida 4155751 34474

Fort Wayne Medical Oncology And Hematology /ID# 277336
Fort Wayne 4920423, Indiana 4921868 46804

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.