Recruiting
Phase 2

ABBV-706 & Atezolizumab

Sponsor:

AbbVie

Code:

NCT07155174

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-706

Atezolizumab

Etoposide

Carboplatin

Carboplatin

Study Details

Brief 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.

Conditions

Small Cell Lung Cancer

Study ID

NCT07155174

Start date

Nov 25, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ABBV-706

Intravenous (IV) Infusion

Atezolizumab

IV Infusion

Etoposide

IV Infusion

Carboplatin

IV Injection

Carboplatin

IV Infusion

Lurbinectedin

IV Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AE)s [ Time Frame: Up to 69.5 Months ]
  • Progression-Free Survival (PFS) Based on Investigator Assessment [ Time Frame: Up to Approximately 24 Months ]

Central Contacts and Locations

Central contacts

Locations

Yale University School of Medicine /ID# 278181

Recruiting

New Haven, Connecticut, United States, 06510

University of Florida College of Medicine /ID# 277496

Recruiting

Gainesville, Florida, United States, 32610

Ocala Oncology Center /ID# 278269

Recruiting

Ocala, Florida, United States, 34474

Moffitt Cancer Center /ID# 277573

Recruiting

Tampa, Florida, United States, 33612

Fort Wayne Medical Oncology And Hematology /ID# 277336

Recruiting

Fort Wayne, Indiana, United States, 46804

Baptist Health Lexington /ID# 277729

Recruiting

Lexington, Kentucky, United States, 40503

Dana-Farber Cancer Institute /ID# 277732

Recruiting

Boston, Massachusetts, United States, 02215

Missouri Cancer Associates /ID# 278299

Recruiting

Columbia, Missouri, United States, 65201

University Hospitals Cleveland Medical Center /ID# 277556

Recruiting

Cleveland, Ohio, United States, 44106

The University of Texas MD Anderson Cancer Center /ID# 277929

Recruiting

Houston, Texas, United States, 77030

Virginia Cancer Specialists - Fairfax /ID# 278298

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AbbVie

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Small Cell Lung Cancer
  • SCLC
  • ABBV-706
  • Etoposide
  • Carboplatin
  • Atezolizumab
  • Lurbinectedin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-25.