Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07155174

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

Led by AbbVie · Updated on 2026-05-13

180

Participants Needed

34

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer requiring first line therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during screening prior to first treatment dose
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Suspected brain metastases must have CT or MRI of the brain before joining the study
Not Eligible

You will not qualify if you...

  • Prior treatment for limited stage small cell lung cancer
  • Known active or symptomatic central nervous system metastases
  • History of interstitial lung disease or pneumonitis needing systemic steroids, or evidence of active ILD/pneumonitis on chest CT scan at screening
  • Any clinically significant condition that would impair participation or with life expectancy less than 3 months

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 34 locations

1

Yale University School of Medicine /ID# 278181

New Haven, Connecticut, United States, 06510

Actively Recruiting

2

Ocala Oncology Center /ID# 278269

Ocala, Florida, United States, 34474

Actively Recruiting

3

Moffitt Cancer Center /ID# 277573

Tampa, Florida, United States, 33612

Actively Recruiting

4

Fort Wayne Medical Oncology And Hematology /ID# 277336

Fort Wayne, Indiana, United States, 46804

Actively Recruiting

5

Baptist Health Lexington /ID# 277729

Lexington, Kentucky, United States, 40503

Actively Recruiting

6

University Hospitals Cleveland Medical Center /ID# 277556

Cleveland, Ohio, United States, 44106

Actively Recruiting

7

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

Houston, Texas, United States, 77030

Actively Recruiting

8

Virginia Cancer Specialists - Fairfax /ID# 278298

Fairfax, Virginia, United States, 22031

Actively Recruiting

9

Groupe Sante CHC - Clinique du MontLegia /ID# 276783

Liège, Liege, Belgium, 4000

Actively Recruiting

10

AZ Maria Middelares /ID# 277027

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

11

Lungenfachklinik Immenhausen /ID# 278005

Immenhausen, Hesse, Germany, 34376

Actively Recruiting

12

Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466

Marburg, Hesse, Germany, 35043

Actively Recruiting

13

Meir Medical Center /ID# 277292

Kfar Saba, Central District, Israel, 4428164

Actively Recruiting

14

Assuta Ashdod Medical Center /ID# 276661

Ashdod, Southern District, Israel, 7747600

Actively Recruiting

15

The Chaim Sheba Medical Center /ID# 276660

Ramat Gan, Tel Aviv, Israel, 5265601

Actively Recruiting

16

Rambam Health Care Campus- Haifa /ID# 276663

Haifa, Israel, 3525408

Actively Recruiting

17

Hadassah Medical Center-Hebrew University /ID# 276662

Jerusalem, Israel, 91120

Actively Recruiting

18

National Cancer Center Hospital East /ID# 277239

Kashiwa-shi, Chiba, Japan, 277-8577

Actively Recruiting

19

Shizuoka Cancer Center /ID# 277243

Sunto-gun, Shizuoka, Japan, 411-8777

Actively Recruiting

20

Tokyo Metropolitan Komagome Hospital /ID# 277335

Bunkyo Ku, Tokyo, Japan, 113-8677

Actively Recruiting

21

National Cancer Center Hospital /ID# 277237

Chuo-Ku, Tokyo, Japan, 104-0045

Actively Recruiting

22

Wakayama Medical University Hospital /ID# 277260

Wakayama, Wakayama, Japan, 641-8510

Actively Recruiting

23

National Cancer Center /ID# 277434

Goyang-si, Gyeonggido, South Korea, 10408

Actively Recruiting

24

Chungbuk National University Hospital /ID# 277429

Cheongju-si, North Chungcheong, South Korea, 28644

Actively Recruiting

25

Seoul National University Hospital /ID# 277271

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

26

Yonsei University Health System Severance Hospital /ID# 277597

Seoul, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

27

Asan Medical Center /ID# 277603

Seoul, Seoul Teugbyeolsi, South Korea, 05505

Actively Recruiting

28

Complejo Hospitalario Universitario A Coruña /ID# 276922

A Coruña, A Coruna, Spain, 15006

Actively Recruiting

29

Hospital Regional Universitario de Malaga /ID# 276927

Málaga, Andalusia, Spain, 29010

Actively Recruiting

30

Hospital Clinic de Barcelona /ID# 276878

Barcelona, Spain, 08036

Actively Recruiting

31

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267

Kaohsiung City, Taiwan, 807

Actively Recruiting

32

Chung Shan Medical University Hospital /ID# 277660

Taichung, Taiwan, 402

Actively Recruiting

33

Taipei Veterans General Hospital /ID# 277263

Taipei, Taiwan, 112

Actively Recruiting

34

Linkou Chang Gung Memorial Hospital /ID# 277264

Taoyuan City, Taiwan, 333

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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