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NCT07365241Recrutement en cours

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

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Résumé

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.

Critères d'inclusion

• 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.

Critères d'exclusion

• 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

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

Voir la fiche officielle de l'essai
Statut
Recrutement en cours
Phase
Phase 3
Type d'étude
Interventionnelle
Pays
Suisse, France, Allemagne, Autriche, États-Unis, Belgique, Brésil, Grèce, Japon, Espagne
Promoteur
AbbVie(Industrie)
N° de protocole
M23-384
Pathologies
Small Cell Lung Cancer
Interventions
Médicament

Traitements évalués

  • ABBV-706
  • Topotecan
  • Topotecan
  • Lurbinectedin
  • Amrubicin

Lieux · 72

  • Basel Town, SuisseUniversity Hospital Basel /ID# 280787Recrute dans ce centre
  • Geneva, SuisseHopitaux Universitaires de Geneve /ID# 280748Recrute dans ce centre
  • Lausanne, SuisseCentre Hospitalier Universitaire Vaudois /ID# 280847Recrute dans ce centre
  • Lugano, SuisseEOC Ospedale Regionale Lugano /ID# 280583Recrute dans ce centre
  • Marseille, FranceAssistance Publique Hopitaux de Marseille - Hopital Nord /ID# 280600Recrute dans ce centre
  • Würzburg, AllemagneUniverstaetsklinikum Wuerzburg /ID# 280834Recrute dans ce centre
  • Kassel, AllemagneKlinikum Kassel /ID# 280427Recrute dans ce centre
  • Cologne, AllemagneUniversitaetsklinikum Koeln /ID# 280867Recrute dans ce centre
  • Cologne, AllemagneKlinikum Koeln-Merheim /ID# 280958Recrute dans ce centre
  • Krems, AutricheUniversitaetsklinikum Krems /ID# 280608Recrute dans ce centre
  • Linz, AutricheOrdensklinikum Linz Elisabethinen /ID# 281314Recrute dans ce centre
  • Birmingham, États-UnisBirmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063Recrute dans ce centre
  • Mobile, États-UnisUsa Mitchell Cancer Institute /ID# 280198Recrute dans ce centre
  • Goodyear, États-UnisCity Of Hope - Phoenix /ID# 281323Recrute dans ce centre
  • Duarte, États-UnisCity of Hope National Medical Center /ID# 281322Recrute dans ce centre
  • Irvine, États-UnisCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396Recrute dans ce centre
  • Fort Myers, États-UnisFlorida Cancer Specialists & Research Institute - South /ID# 281387Recrute dans ce centre
  • Orlando, États-UnisOrlando Health Cancer Institute /ID# 280418Recrute dans ce centre
  • Tampa, États-UnisMoffitt Cancer Center /ID# 279732Recrute dans ce centre
  • Newnan, États-UnisCity Of Hope - Atlanta /ID# 279929Recrute dans ce centre
  • Chicago, États-UnisUniversity of Chicago Medical Center /ID# 280149Recrute dans ce centre
  • Peoria, États-UnisOSF St. Francis Medical Center /ID# 279930Recrute dans ce centre
  • Springfield, États-UnisSpringfield Clinic - First /ID# 281309Recrute dans ce centre
  • Zion, États-UnisCity Of Hope - Chicago /ID# 281335Recrute dans ce centre
  • Indianapolis, États-UnisFranciscan St. Francis Health /ID# 279788Recrute dans ce centre
  • Louisville, États-UnisBaptist Health Louisville /ID# 280025Recrute dans ce centre
  • Boston, États-UnisDana-Farber Cancer Institute /ID# 279690Recrute dans ce centre
  • Grand Rapids, États-UnisCancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955Recrute dans ce centre
  • Edina, États-UnisMinnesota Oncology - Edina Clinic /ID# 280698Recrute dans ce centre
  • Rochester, États-UnisMayo Clinic Hospital Rochester /ID# 279784Recrute dans ce centre

Au total, dans le monde, les 72 centres listés au registre recrutent.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 23 septembre 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

+ 42 autres lieux

Autres identifiants

  • 2025-523819-11 · autre identifiant
  • 2025 · financement NIH

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.