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Clinical Trials in Spain / NCT07365241
Recruiting Phase 3

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

NCT07365241 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Phase 3
Started
2026-07-02
Last updated
2026-09-22

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

ABBV-706 →Topotecan →Topotecan →Lurbinectedin →Amrubicin →

ABBV-706: Intravenous (IV) Infusion

Topotecan: IV Infusion

Topotecan: Oral

Lurbinectedin: IV Infusion

Amrubicin: IV Infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063 Birmingham Alabama Recruiting
Usa Mitchell Cancer Institute /ID# 280198 Mobile Alabama Recruiting
City Of Hope - Phoenix /ID# 281323 Goodyear Arizona Recruiting
City of Hope National Medical Center /ID# 281322 Duarte California Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396 Irvine California Recruiting
Florida Cancer Specialists & Research Institute - South /ID# 281387 Fort Myers Florida Recruiting
Orlando Health Cancer Institute /ID# 280418 Orlando Florida Recruiting
Moffitt Cancer Center /ID# 279732 Tampa Florida Recruiting
City Of Hope - Atlanta /ID# 279929 Newnan Georgia Recruiting
University of Chicago Medical Center /ID# 280149 Chicago Illinois Recruiting
OSF St. Francis Medical Center /ID# 279930 Peoria Illinois Recruiting
Springfield Clinic - First /ID# 281309 Springfield Illinois Recruiting
City Of Hope - Chicago /ID# 281335 Zion Illinois Recruiting
Franciscan St. Francis Health /ID# 279788 Indianapolis Indiana Recruiting
Baptist Health Louisville /ID# 280025 Louisville Kentucky Recruiting
Dana-Farber Cancer Institute /ID# 279690 Boston Massachusetts Recruiting
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955 Grand Rapids Michigan Recruiting
Minnesota Oncology - Edina Clinic /ID# 280698 Edina Minnesota Recruiting
Mayo Clinic Hospital Rochester /ID# 279784 Rochester Minnesota Recruiting
Inspira Medical Center Mullica Hill /ID# 280574 Mullica Hill New Jersey Recruiting
FirstHealth of the Carolinas- Speciality Center /ID# 279857 Pinehurst North Carolina Recruiting
Oncology Hematology Care - Fairfield /ID# 280641 Fairfield Ohio Recruiting
Willamette Valley Cancer Institute and Research Center /ID# 280617 Eugene Oregon Recruiting
Oregon Health and Science University /ID# 280071 Portland Oregon Recruiting
St. Lukes University Hospital /ID# 280204 Bethlehem Pennsylvania Recruiting
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 280619 Knoxville Tennessee Recruiting
University Of Tennessee Medical Center /ID# 279896 Knoxville Tennessee Recruiting
Baptist Memorial Hospital /ID# 281405 Memphis Tennessee Recruiting
SCRI Oncology Partners /ID# 279779 Nashville Tennessee Recruiting
Vanderbilt University Medical Center /ID# 280169 Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center /ID# 280070 Houston Texas Recruiting
Texas Oncology - Northeast Texas /ID# 280642 Tyler Texas Recruiting
Blue Ridge Cancer Care - Blacksburg /ID# 281583 Blacksburg Virginia Recruiting
Virginia Cancer Specialists - Fairfax /ID# 280710 Fairfax Virginia Recruiting
Shenandoah Oncology /ID# 280699 Winchester Virginia Recruiting
West Virginia University Hospitals /ID# 279883 Morgantown West Virginia Recruiting
University of Wisconsin /ID# 279909 Madison Wisconsin Recruiting
Universitaetsklinikum Krems /ID# 280608 Krems Lower Austria Recruiting
Ordensklinikum Linz Elisabethinen /ID# 281314 Linz Upper Austria Recruiting
AZ-Delta. /ID# 280341 Roeselare West-Vlaanderen Recruiting

+ 31 more sites — see the full list on the official registry below.

More AbbVie trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07365241 on ClinicalTrials.gov ↗ ← All trials in Spain