A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer
Purpose
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, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide. Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC [topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)]. The estimated duration of the study is approximately 53 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.
Condition
- Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC). - Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as: - In the 1L and 2L setting respectively, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI, if eligible for CPI) and 2L tarlatamab; or - In the 1L and 2L setting, platinum-based chemotherapy (i.e., carboplatin and etoposide with atezolizumab and lurbinectedin in combination with atezolizumab maintenance and 2L tarlatamab; or - In the 1L setting, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI if eligible) in combination with tarlatamab in frontline induction and/or maintenance - Participants must be considered suitable to receive SOC comparator (topotecan, lurbinectedin, or amrubicin). - Participants must 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. - Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. - Participants with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are: - Previously treated and not requiring anticonvulsants and steroids for at least 7 days prior to first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone dose of ≤ 10 mg/day are eligible or; - Untreated and asymptomatic not requiring anticonvulsants and steroids for at least 7 days prior to the first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone of ≤ 10 mg/day are eligible.
Exclusion Criteria
- Participants with known active/symptomatic central nervous system metastases. - Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan. - Participants with any clinically significant conditions that would adversely affect the participation in the study, and the subject should have a life expectancy of at least 3 months. - Participants who have received prior treatment with a seizure-related 6 homolog (SEZ6) targeted Antibody drug conjugate (ADC), other targeted ADCs, or any other investigational agent not including tarlatamab in 1L. - Participants who have received prior treatment with any Top1i such as topotecan, irinotecan, belotecan, camptothecin, rubitecan, exatecan or locally approved topoisomerase I inhibitor (Top1i) payload.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABBV-706 |
Participants will receive ABBV-706 as part of the 53 month study duration. |
|
|
Active Comparator Stand of Care (SOC) |
Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration. |
|
Recruiting Locations
Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063
Birmingham, Alabama 35243
Birmingham, Alabama 35243
Usa Mitchell Cancer Institute /ID# 280198
Mobile, Alabama 36604
Mobile, Alabama 36604
City Of Hope - Phoenix /ID# 281323
Goodyear, Arizona 85338
Goodyear, Arizona 85338
City of Hope National Medical Center /ID# 281322
Duarte, California 91010
Duarte, California 91010
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396
Irvine, California 92618
Irvine, California 92618
Orlando Health Cancer Institute /ID# 280418
Orlando, Florida 32806
Orlando, Florida 32806
City Of Hope - Atlanta /ID# 279929
Newnan, Georgia 30265
Newnan, Georgia 30265
OSF St. Francis Medical Center /ID# 279930
Peoria, Illinois 61637-0001
Peoria, Illinois 61637-0001
Springfield Clinic - First /ID# 281309
Springfield, Illinois 62702
Springfield, Illinois 62702
City Of Hope - Chicago /ID# 281335
Zion, Illinois 60099
Zion, Illinois 60099
Franciscan St. Francis Health /ID# 279788
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Minnesota Oncology - Edina Clinic /ID# 280698
Edina, Minnesota 55435
Edina, Minnesota 55435
Oncology Hematology Care - Fairfield /ID# 280641
Fairfield, Ohio 45014
Fairfield, Ohio 45014
Willamette Valley Cancer Institute and Research Center /ID# 280617
Eugene, Oregon 97401
Eugene, Oregon 97401
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 280619
Knoxville, Tennessee 37909
Knoxville, Tennessee 37909
University Of Tennessee Medical Center /ID# 279896
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
Baptist Memorial Hospital /ID# 281405
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Vanderbilt University Medical Center /ID# 280169
Nashville, Tennessee 37232
Nashville, Tennessee 37232
The University of Texas MD Anderson Cancer Center /ID# 280070
Houston, Texas 77030
Houston, Texas 77030
Texas Oncology - Northeast Texas /ID# 280642
Tyler, Texas 75702
Tyler, Texas 75702
Shenandoah Oncology /ID# 280699
Winchester, Virginia 22601
Winchester, Virginia 22601
West Virginia University Hospitals /ID# 279883
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
University of Wisconsin /ID# 279909
Madison, Wisconsin 53792-0001
Madison, Wisconsin 53792-0001
More Details
- Status
- Recruiting
- Sponsor
- AbbVie