RecruitingPhase 2

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

United States, Belgium, China180 participantsStarted 2025-11-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 2 trial, what do we know so far about the safety and effectiveness of ABBV-706 combined with atezolizumab, and how does that uncertainty compare to what's already known about the standard of care options for my stage of small cell lung cancer?
2One of the main things this trial is measuring is the number of participants who experience adverse events — what kinds of side effects have been seen with ABBV-706 so far, and how might combining it with atezolizumab affect my risk compared to going with standard first-line treatment?
3The trial is measuring progression-free survival based on how the investigator assesses my scans and response — how often would I need to come in for evaluations, and what does that monitoring schedule actually look like in practice for someone in my situation?
4Since this trial is for previously untreated extensive stage small cell lung cancer, if I enroll and the combination doesn't work or I experience serious side effects, would I still have access to the standard first-line treatments I'd be giving up by joining this study?
5This study is still in Phase 2 and is actively recruiting — does my oncologist think my specific health profile and the stage of my diagnosis make me a reasonable candidate to discuss with the trial team, or would starting with an established regimen first make more sense for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events (AE)s

Timeframe: Up to 69.5 Months

Progression-Free Survival (PFS) Based on Investigator Assessment

Timeframe: Up to Approximately 24 Months

Trial details

NCT IDNCT07155174

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-05

Contact for this trial

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

View on ClinicalTrials.gov More Small Cell Lung Cancer trials