ABBV-706 plus atezolizumab versus standard first-line therapy for extensive-stage small cell lung cancer
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)
This trial will test whether giving ABBV-706 with atezolizumab is safer or more effective than standard first-line chemo plus atezolizumab in adults with previously untreated extensive-stage small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | atezolizumab |
| Locations | 34 sites (New Haven, Connecticut and 33 other locations) |
| Trial ID | NCT07155174 on ClinicalTrials.gov |
What this trial studies
Adults with previously untreated extensive-stage SCLC and ECOG 0–1 will be enrolled at multiple sites and receive either one of two IV doses of ABBV-706 with IV atezolizumab or the standard regimen of etoposide, carboplatin and atezolizumab (with optional lurbinectedin). The study includes a safety lead-in to define tolerable ABBV-706 dosing followed by an expansion phase to compare adverse events and change in disease activity across arms, targeting about 180 participants worldwide. Key eligibility requires measurable disease and brain imaging to rule out active symptomatic CNS metastases, while major exclusions include prior limited-stage therapy and active interstitial lung disease. Primary outcomes focus on safety, optimal dose selection, and change in disease activity measured by RECIST v1.1.
Who should consider this trial
Good fit: Adults with newly diagnosed extensive-stage small cell lung cancer who have not received prior systemic therapy, have measurable disease, and have ECOG performance status 0–1 are ideal candidates.
Not a fit: Patients with active symptomatic brain metastases, prior treatment for limited-stage SCLC, active interstitial lung disease or pneumonitis requiring steroids, or ECOG >1 are unlikely to be eligible or to benefit from this trial.
Why it matters
Potential benefit: If successful, the combination could produce higher tumor response rates or longer time to progression than current first-line treatment, offering a new option for patients.
How similar studies have performed: Adding atezolizumab to chemotherapy has previously improved survival in first-line ES-SCLC, but ABBV-706 is investigational and combining this type of agent with immunotherapy is a novel approach with mixed results in earlier efforts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut and 33 other locations
- Yale University School of Medicine /ID# 278181 — New Haven, Connecticut, United States (Recruiting)
- Ocala Oncology Center /ID# 278269 — Ocala, Florida, United States (Recruiting)
- Moffitt Cancer Center /ID# 277573 — Tampa, Florida, United States (Recruiting)
- Fort Wayne Medical Oncology And Hematology /ID# 277336 — Fort Wayne, Indiana, United States (Recruiting)
- Baptist Health Lexington /ID# 277729 — Lexington, Kentucky, United States (Recruiting)
- University Hospitals Cleveland Medical Center /ID# 277556 — Cleveland, Ohio, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center /ID# 277929 — Houston, Texas, United States (Recruiting)
- Virginia Cancer Specialists - Fairfax /ID# 278298 — Fairfax, Virginia, United States (Recruiting)
- Groupe Sante CHC - Clinique du MontLegia /ID# 276783 — Liège, Liege, Belgium (Recruiting)
- AZ Maria Middelares /ID# 277027 — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Lungenfachklinik Immenhausen /ID# 278005 — Immenhausen, Hesse, Germany (Recruiting)
- Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466 — Marburg, Hesse, Germany (Recruiting)
- Meir Medical Center /ID# 277292 — Kfar Saba, Central District, Israel (Recruiting)
- Assuta Ashdod Medical Center /ID# 276661 — Ashdod, Southern District, Israel (Recruiting)
- The Chaim Sheba Medical Center /ID# 276660 — Ramat Gan, Tel Aviv, Israel (Recruiting)
- Rambam Health Care Campus- Haifa /ID# 276663 — Haifa, Israel (Recruiting)
- Hadassah Medical Center-Hebrew University /ID# 276662 — Jerusalem, Israel (Recruiting)
- National Cancer Center Hospital East /ID# 277239 — Kashiwa-shi, Chiba, Japan (Recruiting)
- Shizuoka Cancer Center /ID# 277243 — Sunto-gun, Shizuoka, Japan (Recruiting)
- Tokyo Metropolitan Komagome Hospital /ID# 277335 — Bunkyo Ku, Tokyo, Japan (Recruiting)
- National Cancer Center Hospital /ID# 277237 — Chuo-Ku, Tokyo, Japan (Recruiting)
- Wakayama Medical University Hospital /ID# 277260 — Wakayama, Wakayama, Japan (Recruiting)
- National Cancer Center /ID# 277434 — Goyang-si, Gyeonggido, South Korea (Recruiting)
- Chungbuk National University Hospital /ID# 277429 — Cheongju-si, North Chungcheong, South Korea (Recruiting)
- Seoul National University Hospital /ID# 277271 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Yonsei University Health System Severance Hospital /ID# 277597 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Asan Medical Center /ID# 277603 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Complejo Hospitalario Universitario A Coruña /ID# 276922 — A Coruña, A Coruna, Spain (Recruiting)
- Hospital Regional Universitario de Malaga /ID# 276927 — Málaga, Andalusia, Spain (Recruiting)
- Hospital Clinic de Barcelona /ID# 276878 — Barcelona, Spain (Recruiting)
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267 — Kaohsiung City, Taiwan (Recruiting)
- Chung Shan Medical University Hospital /ID# 277660 — Taichung, Taiwan (Recruiting)
- Taipei Veterans General Hospital /ID# 277263 — Taipei, Taiwan (Recruiting)
- Linkou Chang Gung Memorial Hospital /ID# 277264 — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.