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NCT07365241RecruitingPhase 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

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)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026

Brief summary (registry, in English)

• To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan, lurbinectedin, or amrubicin) in terms of objective response (OR) as measured by ORR based on blinded independent central review (BICR) assessment per RECIST v1.1. • To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan, lurbinectedin, or amrubicin) in terms of efficacy as measured by overall survival (OS).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
125 (estimated)
First submitted
1 Apr 2026
Start date
3 Aug 2026
Lead sponsor
AbbVie Deutschland GmbH & Co. KG
Diseases
Lung cancer
NCT number
NCT07365241
EU CT number
2025-523819-11-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 125
  • 43 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.

Other illness

  • Participants with any clinically significant conditions that would adversely affect the subject's participation in the study, and the subject should have a life expectancy of at least 3 months.

Other

  • Participants with known active/symptomatic central nervous system metastases

Who the study is looking for

  • Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC).
  • Participants must be considered suitable to receive Standard of care (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 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 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Universitaetsklinikum Krems
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Krems An Der DonauAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Universitaetsklinikum Koeln AöR
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CologneGermanyRecruiting
Kliniken der Stadt Koeln gGmbH
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CologneGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Asklepios Klinik Gauting GmbH
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GautingGermanyRecruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyRecruiting
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyRecruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyRecruiting
Klinikum Kassel GmbH
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KasselGermanyRecruiting
Muehlenkreiskliniken AöR
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MindenGermanyRecruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceRecruiting
Institut Curie
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ParisFranceRecruiting
Fondation Hôpital Saint-Joseph
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Henry Dunant Hospital Center
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AthensGreeceRecruiting
Metropolitan Hospital
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PireasGreeceRecruiting
Athens Medical Center S.A.
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ThessalonikiGreeceRecruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyRecruiting
Cliniche Gavazzeni S.p.A.
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BergamoItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
Azienda Ospedaliera S Giovanni Addolorata
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RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.