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
SEZanne
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)
2 other identifiers
interventional
180
11 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2025
Longer than P75 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
November 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2031
June 9, 2026
June 1, 2026
3.4 years
August 28, 2025
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 69.5 Months
Progression-Free Survival (PFS) Based on Investigator Assessment
PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first.
Up to Approximately 24 Months
Secondary Outcomes (4)
Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment
Up to Approximately 24 Months
Duration of Response (DoR) Based on Investigator Assessment
Up to Approximately 24 Months
Disease Control (DC) Based on Investigator Assessment
Up to Approximately 24 Months
OS
Up to Approximately 28 Months
Study Arms (6)
Safety Lead-In: ABBV-706 Dose A
EXPERIMENTALParticipants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Safety Lead-In: ABBV-706 Dose B
EXPERIMENTALParticipants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Safety Lead-In: Stand of Care (SOC)
EXPERIMENTALParticipants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Expansion: ABBV-706 Dose A
EXPERIMENTALParticipants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Expansion: ABBV-706 Dose B
EXPERIMENTALParticipants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Expansion: SOC
EXPERIMENTALParticipants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Interventions
Intravenous (IV) Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (49)
Yale University School of Medicine /ID# 278181
New Haven, Connecticut, 06510, United States
Ocala Oncology Center /ID# 278269
Ocala, Florida, 34474, United States
Moffitt Cancer Center /ID# 277573
Tampa, Florida, 33612, United States
Fort Wayne Medical Oncology And Hematology /ID# 277336
Fort Wayne, Indiana, 46804, United States
Baptist Health Lexington /ID# 277729
Lexington, Kentucky, 40503, United States
Dana-Farber Cancer Institute /ID# 277732
Boston, Massachusetts, 02215, United States
University Hospitals Cleveland Medical Center /ID# 277556
Cleveland, Ohio, 44106, United States
The University of Texas MD Anderson Cancer Center /ID# 277929
Houston, Texas, 77030, United States
Virginia Cancer Specialists - Fairfax /ID# 278298
Fairfax, Virginia, 22031, United States
Grand Hopital de Charleroi - Les Viviers /ID# 276897
Charleroi, Hainaut, 6280, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 276783
Liège, Liege, 4000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781
Hasselt, Limburg, 3500, Belgium
AZ Maria Middelares /ID# 277027
Ghent, Oost-Vlaanderen, 9000, Belgium
Lungenfachklinik Immenhausen /ID# 278005
Immenhausen, Hesse, 34376, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466
Marburg, Hesse, 35043, Germany
Evangelische Lungenklinik Berlin /ID# 277094
Berlin, 13125, Germany
Meir Medical Center /ID# 277292
Kefar Sava, Central District, 4428164, Israel
Assuta Ashdod Medical Center /ID# 276661
Ashdod, Southern District, 7747600, Israel
The Chaim Sheba Medical Center /ID# 276660
Ramat Gan, Tel Aviv, 5265601, Israel
Rambam Health Care Campus- Haifa /ID# 276663
Haifa, 3109601, Israel
Hadassah Medical Center-Hebrew University /ID# 276662
Jerusalem, 91120, Israel
National Cancer Center Hospital East /ID# 277239
Kashiwa-shi, Chiba, 277-8577, Japan
Shizuoka Cancer Center /ID# 277243
Sunto-gun, Shizuoka, 411-8777, Japan
Tokyo Metropolitan Komagome Hospital /ID# 277335
Bunkyo Ku, Tokyo, 113-8677, Japan
National Cancer Center Hospital /ID# 277237
Chuo-Ku, Tokyo, 104-0045, Japan
Wakayama Medical University Hospital /ID# 277260
Wakayama, Wakayama, 641-8510, Japan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 276907
Poznan, Greater Poland Voivodeship, 60-569, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910
Lublin, Lublin Voivodeship, 20-090, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 277112
Warsaw, Masovian Voivodeship, 02-781, Poland
University Clinical Center Serbia /ID# 277007
Belgrade, Beograd, 11000, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277013
Belgrade, Beograd, 11080, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277003
Kamenitz, Sremski Okrug, 21208, Serbia
University Clinical Center Kragujevac /ID# 277179
Kragujevac, Sumadijski Okrug, 34000, Serbia
National Cancer Center /ID# 277434
Goyang-si, Gyeonggido, 10408, South Korea
Chungbuk National University Hospital /ID# 277429
Cheongju-si, North Chungcheong, 28644, South Korea
Seoul National University Hospital /ID# 277271
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Yonsei University Health System Severance Hospital /ID# 277597
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center /ID# 277603
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 277615
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 276922
A Coruña, A Coruna, 15006, Spain
Hospital Regional Universitario de Malaga /ID# 276927
Málaga, Andalusia, 29010, Spain
Hospital Clinic de Barcelona /ID# 276878
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre /ID# 277251
Madrid, 28041, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277725
Kaohsiung City, 833, Taiwan
Chung Shan Medical University Hospital /ID# 277660
Taichung, 402, Taiwan
Taipei Veterans General Hospital /ID# 277263
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277264
Taoyuan City, 333, Taiwan
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076
Ankara, 06620, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2025
First Posted
September 4, 2025
Study Start
November 25, 2025
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
September 1, 2031
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.