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RecruitingNCT07155174SEZanneUpdated Sep 23, 2026

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

A Phase 2 interventional study of ABBV-706 and Atezolizumab in Small Cell Lung Cancer, sponsored by AbbVie. Recruiting at 68 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Small Cell Lung Cancer

Keywords

  • Small Cell Lung Cancer
  • SCLC
  • ABBV-706
  • Etoposide
  • Carboplatin
  • Atezolizumab
  • Lurbinectedin
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study 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.

    Drug: ABBV-706 · Drug: Atezolizumab

  • 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 · Drug: Atezolizumab

  • 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 · Drug: Etoposide · Drug: Carboplatin · Drug: Lurbinectedin

  • 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 · Drug: Atezolizumab

  • 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 · Drug: Atezolizumab

  • 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 · Drug: Etoposide · Drug: Carboplatin · Drug: Lurbinectedin

Interventions

  • DrugABBV-706

    Intravenous (IV) Infusion

  • DrugAtezolizumab

    IV Infusion

  • DrugEtoposide

    IV Infusion

  • DrugCarboplatin

    IV Injection

  • DrugCarboplatin

    IV Infusion

  • DrugLurbinectedin

    IV Infusion

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 69.5 Months

  2. 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.

    Time frame: Up to Approximately 24 Months

Secondary outcomes

  1. Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment

    OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR)/partial response (PR) per RECIST v1.1 as determined by investigator prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the proportion of subjects achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI).

    Time frame: Up to Approximately 24 Months

  2. Duration of Response (DoR) Based on Investigator Assessment

    DoR is defined as time from the initial response of CR/PR until the first documentation of radiographical PD according to RECIST v1.1 by investigator or death from any cause, whichever occurs first.

    Time frame: Up to Approximately 24 Months

  3. Disease Control (DC) Based on Investigator Assessment

    DC is defined as achieving an OR or stable disease (SD) according to RECIST v1.1 by investigator at any time prior to subsequent anti-cancer therapy.

    Time frame: Up to Approximately 24 Months

  4. OS

    OS, is defined as the time from randomization to death from any cause.

    Time frame: Up to Approximately 28 Months

06

Study locations

68 of 68 sites recruiting
  • Yale University School of Medicine /ID# 278181
    New Haven, Connecticut 06510, United States
    Recruiting
  • University of Florida College of Medicine /ID# 277496
    Gainesville, Florida 32610, United States
    Recruiting
  • Ocala Oncology Center /ID# 278269
    Ocala, Florida 34474, United States
    Recruiting
  • Moffitt Cancer Center /ID# 277573
    Tampa, Florida 33612, United States
    Recruiting
  • Fort Wayne Medical Oncology And Hematology /ID# 277336
    Fort Wayne, Indiana 46804, United States
    Recruiting
  • Baptist Health Lexington /ID# 277729
    Lexington, Kentucky 40503, United States
    Recruiting
  • Dana-Farber Cancer Institute /ID# 277732
    Boston, Massachusetts 02215, United States
    Recruiting
  • Missouri Cancer Associates /ID# 278299
    Columbia, Missouri 65201, United States
    Recruiting
  • University Hospitals Cleveland Medical Center /ID# 277556
    Cleveland, Ohio 44106, United States
    Recruiting
  • The University of Texas MD Anderson Cancer Center /ID# 277929
    Houston, Texas 77030, United States
    Recruiting
  • Virginia Cancer Specialists - Fairfax /ID# 278298
    Fairfax, Virginia 22031, United States
    Recruiting
  • Grand Hopital de Charleroi - Les Viviers /ID# 276897
    Charleroi, Hainaut 6280, Belgium
    Recruiting
  • Groupe Sante CHC - Clinique du MontLegia /ID# 276783
    Liège, Liege 4000, Belgium
    Recruiting
  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781
    Hasselt, Limburg 3500, Belgium
    Recruiting
  • AZ Maria Middelares /ID# 277027
    Ghent, Oost-Vlaanderen 9000, Belgium
    Recruiting
  • Cancer Hospital - Chinese Academy of Medical Sciences /ID# 277167
    Beijing, Beijing Municipality 100021, China
    Recruiting
  • Henan Cancer Hospital /ID# 277059
    Zhengzhou, Henan 450008, China
    Recruiting
  • Union Hospital Tongji Medical College /ID# 277912
    Wuhan, Hubei 430048, China
    Recruiting
  • The First affiliated hospital of Nanchang University /ID# 277247
    Nanchang, Jiangxi 330006, China
    Recruiting
  • Shanghai East Hospital /ID# 277111
    Shanghai, Shanghai Municipality 200120, China
    Recruiting
  • Shanghai Pulmonary Hospital /ID# 276960
    Shanghai, Shanghai Municipality 200433, China
    Recruiting
  • West China Hospital of Sichuan University /ID# 277852
    Chengdu, Sichuan 610041, China
    Recruiting
  • Lungenfachklinik Immenhausen /ID# 278005
    Immenhausen, Hesse 34376, Germany
    • Site Coordinator · Contact · +49 5673 5011573
    Recruiting
  • Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466
    Marburg, Hesse 35043, Germany
    Recruiting
  • Evangelische Lungenklinik Berlin /ID# 277094
    Berlin, 13125, Germany
    Recruiting
  • Meir Medical Center /ID# 277292
    Kefar Sava, Central District 4428164, Israel
    Recruiting
  • Assuta Ashdod Medical Center /ID# 276661
    Ashdod, Southern District 7747600, Israel
    Recruiting
  • The Chaim Sheba Medical Center /ID# 276660
    Ramat Gan, Tel Aviv 5265601, Israel
    Recruiting
  • Rambam Health Care Campus- Haifa /ID# 276663
    Haifa, 3109601, Israel
    Recruiting
  • Hadassah Medical Center-Hebrew University /ID# 276662
    Jerusalem, 91120, Israel
    Recruiting
  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 276792
    Rome, Roma 00144, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 276789
    Orbassano, Torino 10043, Italy
    Recruiting
  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 277744
    Roma, 00128, Italy
    Recruiting
  • National Cancer Center Hospital East /ID# 277239
    Kashiwa-shi, Chiba 277-8577, Japan
    Recruiting
  • Shizuoka Cancer Center /ID# 277243
    Sunto-gun, Shizuoka 411-8777, Japan
    Recruiting
  • Tokyo Metropolitan Komagome Hospital /ID# 277335
    Bunkyo Ku, Tokyo 113-8677, Japan
    Recruiting
  • National Cancer Center Hospital /ID# 277237
    Chuo-Ku, Tokyo 104-0045, Japan
    Recruiting
  • Wakayama Medical University Hospital /ID# 277260
    Wakayama, Wakayama 641-8510, Japan
    Recruiting
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 276907
    Poznan, Greater Poland Voivodeship 60-569, Poland
    Recruiting
  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910
    Lublin, Lublin Voivodeship 20-090, Poland
    Recruiting
  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 277112
    Warsaw, Masovian Voivodeship 02-781, Poland
    Recruiting
  • University Clinical Center Serbia /ID# 277007
    Belgrade, Beograd 11000, Serbia
    Recruiting
  • Clinical Hospital Center - Bezanijska Kosa /ID# 277013
    Belgrade, Beograd 11080, Serbia
    Recruiting
  • University Clinical Center Nis /ID# 277180
    Niš, Nisavski Okrug 18300, Serbia
    Recruiting
  • Institute For Pulmonary Diseases Of Vojvodina /ID# 277003
    Kamenitz, Sremski Okrug 21208, Serbia
    Recruiting
  • University Clinical Center Kragujevac /ID# 277179
    Kragujevac, Sumadijski Okrug 34000, Serbia
    Recruiting
  • National Cancer Center /ID# 277434
    Goyang-si, Gyeonggido 10408, South Korea
    Recruiting
  • Chungbuk National University Hospital /ID# 277429
    Cheongju-si, North Chungcheong 28644, South Korea
    Recruiting
  • Seoul National University Hospital /ID# 277271
    Seoul, Seoul Teugbyeolsi 03080, South Korea
    Recruiting
  • Yonsei University Health System Severance Hospital /ID# 277597
    Seoul, Seoul Teugbyeolsi 03722, South Korea
    Recruiting
  • Asan Medical Center /ID# 277603
    Seoul, Seoul Teugbyeolsi 05505, South Korea
    Recruiting
  • Samsung Medical Center /ID# 277615
    Seoul, Seoul Teugbyeolsi 06351, South Korea
    Recruiting
  • Hospital Regional Universitario de Malaga /ID# 276927
    Málaga, Andalusia 29010, Spain
    Recruiting
  • Complejo Hospitalario Universitario A Coruna /ID# 276922
    A Coruña, 15006, Spain
    Recruiting
  • Hospital Clinic de Barcelona /ID# 276878
    Barcelona, 08036, Spain
    Recruiting
  • Hospital General Universitario Gregorio Maranon /ID# 276877
    Madrid, 28007, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre /ID# 277251
    Madrid, 28041, Spain
    Recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267
    Kaohsiung City, 807, Taiwan
    Recruiting
  • Kaohsiung Chang Gung Memorial Hospital /ID# 277725
    Kaohsiung City, 833, Taiwan
    Recruiting
  • Chung Shan Medical University Hospital /ID# 277660
    Taichung, 402, Taiwan
    Recruiting
  • Taipei Veterans General Hospital /ID# 277263
    Taipei, 112, Taiwan
    Recruiting
  • Linkou Chang Gung Memorial Hospital /ID# 277264
    Taoyuan City, 333, Taiwan
    Recruiting
  • Adana Sehir Hastanesi /ID# 277082
    Adana, 01370, Turkey (Türkiye)
    Recruiting
  • Memorial Ankara Hastanesi /ID# 276840
    Ankara, 06520, Turkey (Türkiye)
    Recruiting
  • Gazi University Medical Faculty /ID# 276843
    Ankara, 06560, Turkey (Türkiye)
    Recruiting
  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076
    Ankara, 06620, Turkey (Türkiye)
    Recruiting
  • Liv Hospital Ankara /ID# 276842
    Ankara, 06680, Turkey (Türkiye)
    Recruiting
  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276839
    Istanbul, 34722, Turkey (Türkiye)
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07155174
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Sep 4, 2025
Start date
Nov 25, 2025
Primary completion
Apr 2029 (estimated)
Completion
Sep 2031 (estimated)
Last update
Sep 23, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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