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
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 sites (37)
AL
- Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063 · Birmingham, AL 35243More trials in Birmingham
- Usa Mitchell Cancer Institute /ID# 280198 · Mobile, AL 36604More trials in Mobile
AZ
- City Of Hope - Phoenix /ID# 281323 · Goodyear, AZ 85338More trials in Goodyear
CA
- City of Hope National Medical Center /ID# 281322 · Duarte, CA 91010More trials in Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396 · Irvine, CA 92618More trials in Irvine
FL
- Florida Cancer Specialists & Research Institute - South /ID# 281387 · Fort Myers, FL 33901More trials in Fort Myers
- Orlando Health Cancer Institute /ID# 280418 · Orlando, FL 32806More trials in Orlando
- Moffitt Cancer Center /ID# 279732 · Tampa, FL 33612More trials in Tampa
GA
- City Of Hope - Atlanta /ID# 279929 · Newnan, GA 30265More trials in Newnan
IL
- University of Chicago Medical Center /ID# 280149 · Chicago, IL 60637More trials in Chicago
- OSF St. Francis Medical Center /ID# 279930 · Peoria, IL 61637-0001More trials in Peoria
- Springfield Clinic - First /ID# 281309 · Springfield, IL 62702More trials in Springfield
- City Of Hope - Chicago /ID# 281335 · Zion, IL 60099More trials in Zion
IN
- Franciscan St. Francis Health /ID# 279788 · Indianapolis, IN 46237More trials in Indianapolis
KY
- Baptist Health Louisville /ID# 280025 · Louisville, KY 40207More trials in Louisville
MA
- Dana-Farber Cancer Institute /ID# 279690 · Boston, MA 02215More trials in Boston
MI
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955 · Grand Rapids, MI 49503More trials in Grand Rapids
MN
- Minnesota Oncology - Edina Clinic /ID# 280698 · Edina, MN 55435More trials in Edina
- Mayo Clinic Hospital Rochester /ID# 279784 · Rochester, MN 55905More trials in Rochester
NC
- FirstHealth of the Carolinas- Speciality Center /ID# 279857 · Pinehurst, NC 28374More trials in Pinehurst
NJ
- Inspira Medical Center Mullica Hill /ID# 280574 · Mullica Hill, NJ 08062More trials in Mullica Hill
OH
- Oncology Hematology Care - Fairfield /ID# 280641 · Fairfield, OH 45014More trials in Fairfield
OR
- Willamette Valley Cancer Institute and Research Center /ID# 280617 · Eugene, OR 97401More trials in Eugene
- Oregon Health and Science University /ID# 280071 · Portland, OR 97239More trials in Portland
PA
- St. Lukes University Hospital /ID# 280204 · Bethlehem, PA 18015More trials in Bethlehem
TN
- Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 280619 · Knoxville, TN 37909More trials in Knoxville
- University Of Tennessee Medical Center /ID# 279896 · Knoxville, TN 37920More trials in Knoxville
- Baptist Memorial Hospital /ID# 281405 · Memphis, TN 38120More trials in Memphis
- SCRI Oncology Partners /ID# 279779 · Nashville, TN 37203More trials in Nashville
- Vanderbilt University Medical Center /ID# 280169 · Nashville, TN 37232More trials in Nashville
TX
- The University of Texas MD Anderson Cancer Center /ID# 280070 · Houston, TX 77030More trials in Houston
- Texas Oncology - Northeast Texas /ID# 280642 · Tyler, TX 75702More trials in Tyler
VA
- Blue Ridge Cancer Care - Blacksburg /ID# 281583 · Blacksburg, VA 24060More trials in Blacksburg
- Virginia Cancer Specialists - Fairfax /ID# 280710 · Fairfax, VA 22031More trials in Fairfax
- Shenandoah Oncology /ID# 280699 · Winchester, VA 22601More trials in Winchester
WI
- University of Wisconsin /ID# 279909 · Madison, WI 53792-0001More trials in Madison
WV
- West Virginia University Hospitals /ID# 279883 · Morgantown, WV 26506More trials in Morgantown