NCT07365241Recruiting
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
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, 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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Austria, United States, Belgium, Brazil, Greece, Japan, Spain
- Sponsor
- AbbVie(Industry)
- Protocol no.
- M23-384
- Conditions
- Small Cell Lung Cancer
- Interventions
- Drug
Treatments studied
- ABBV-706
- Topotecan
- Topotecan
- Lurbinectedin
- Amrubicin
Locations · 72
- Basel Town, SwitzerlandUniversity Hospital Basel /ID# 280787Recruiting at this site
- Geneva, SwitzerlandHopitaux Universitaires de Geneve /ID# 280748Recruiting at this site
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois /ID# 280847Recruiting at this site
- Lugano, SwitzerlandEOC Ospedale Regionale Lugano /ID# 280583Recruiting at this site
- Marseille, FranceAssistance Publique Hopitaux de Marseille - Hopital Nord /ID# 280600Recruiting at this site
- Würzburg, GermanyUniverstaetsklinikum Wuerzburg /ID# 280834Recruiting at this site
- Kassel, GermanyKlinikum Kassel /ID# 280427Recruiting at this site
- Cologne, GermanyUniversitaetsklinikum Koeln /ID# 280867Recruiting at this site
- Cologne, GermanyKlinikum Koeln-Merheim /ID# 280958Recruiting at this site
- Krems, AustriaUniversitaetsklinikum Krems /ID# 280608Recruiting at this site
- Linz, AustriaOrdensklinikum Linz Elisabethinen /ID# 281314Recruiting at this site
- Birmingham, United StatesBirmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063Recruiting at this site
- Mobile, United StatesUsa Mitchell Cancer Institute /ID# 280198Recruiting at this site
- Goodyear, United StatesCity Of Hope - Phoenix /ID# 281323Recruiting at this site
- Duarte, United StatesCity of Hope National Medical Center /ID# 281322Recruiting at this site
- Irvine, United StatesCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396Recruiting at this site
- Fort Myers, United StatesFlorida Cancer Specialists & Research Institute - South /ID# 281387Recruiting at this site
- Orlando, United StatesOrlando Health Cancer Institute /ID# 280418Recruiting at this site
- Tampa, United StatesMoffitt Cancer Center /ID# 279732Recruiting at this site
- Newnan, United StatesCity Of Hope - Atlanta /ID# 279929Recruiting at this site
- Chicago, United StatesUniversity of Chicago Medical Center /ID# 280149Recruiting at this site
- Peoria, United StatesOSF St. Francis Medical Center /ID# 279930Recruiting at this site
- Springfield, United StatesSpringfield Clinic - First /ID# 281309Recruiting at this site
- Zion, United StatesCity Of Hope - Chicago /ID# 281335Recruiting at this site
- Indianapolis, United StatesFranciscan St. Francis Health /ID# 279788Recruiting at this site
- Louisville, United StatesBaptist Health Louisville /ID# 280025Recruiting at this site
- Boston, United StatesDana-Farber Cancer Institute /ID# 279690Recruiting at this site
- Grand Rapids, United StatesCancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955Recruiting at this site
- Edina, United StatesMinnesota Oncology - Edina Clinic /ID# 280698Recruiting at this site
- Rochester, United StatesMayo Clinic Hospital Rochester /ID# 279784Recruiting at this site
In total, worldwide, all 72 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 42 more locations
Other identifiers
- 2025-523819-11 · other identifier
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.