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NCT07246863Recrutement en cours

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

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Résumé

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Critères d'inclusion

• Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC. • Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent. • Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment. • Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1. • Participants must have life expectancy of at least 3 months as assessed by the Investigator. • Participants must have ECOG performance status ≤1.

Critères d'exclusion

• Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC. • Participants must not have a prior malignancy requiring treatment. • Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis • Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). • Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.

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 2
Type d'étude
Interventionnelle
Pays
Suisse, Allemagne, Italie, États-Unis, Pologne, Roumanie, Espagne
Promoteur
CatalYm GmbH(Industrie)
N° de protocole
CTL-002-004
Pathologies
Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Interventions
Biologique, Autre, Médicament

Traitements évalués

  • Visugromab RDE (recommended dose for expansion)
  • Visugromab 6mg/kg
  • Nivolumab
  • Placebo Saline Infusion
  • Docetaxel

Lieux · 36

  • Basel, SuisseUniversity Hospital BaselRecrute dans ce centre
  • Sankt Gallen, SuisseCantonal Hospital Saint Gallen, Clinic of Oncology and HematologyRecrute dans ce centre
  • Esslingen am Neckar, AllemagneHospital Esslingen GmbHRecrute dans ce centre
  • Heidelberg, AllemagneThorax Clinic HeidelbergRecrute dans ce centre
  • Würzburg, AllemagneUniversity Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical ImmunologyRecrute dans ce centre
  • Bielefeld, AllemagneEvangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine JohannesstiftRecrute dans ce centre
  • Essen, AllemagneClinics Essen-MitteRecrute dans ce centre
  • Moers, AllemagneFoundation Bethanien MoersRecrute dans ce centre
  • Forlì, ItalieInstitute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRSTRecrute dans ce centre
  • Aviano, ItalieOncology Reference CenterRecrute dans ce centre
  • Rome, ItalieNational Cancer Institute Regina Elena, IRCCSRecrute dans ce centre
  • Milan, ItalieEuropean Institute of Oncology (IEO), IRCCSRecrute dans ce centre
  • Candiolo, ItalieInstitute of Cancer Research and Treatment of CandioloRecrute dans ce centre
  • Ravenna, ItalieLocal Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology DepartmentRecrute dans ce centre
  • Birmingham, États-UnisUniversity of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)Recrute dans ce centre
  • Los Angeles, États-UnisUSC Norris Comprehensive Cancer CenterRecrute dans ce centre
  • Mineola, États-UnisNYU Langone Hospital - Long IslandRecrute dans ce centre
  • New York, États-UnisNYU Longone HealthRecrute dans ce centre
  • Durham, États-UnisDuke University Medical CenterRecrute dans ce centre
  • Poznan, PologneMED-Polonia, Sp. z o.o. (LLC)Recrute dans ce centre
  • Craiova, RoumanieSf. Nectarie Oncology CenterRecrute dans ce centre
  • Sibiu, RoumanieClinica Polisano S.R.LRecrute dans ce centre
  • Timișoara, RoumanieSC Oncomed SRLRecrute dans ce centre
  • Jaén, EspagneUniversity Hospital of JaenRecrute dans ce centre
  • Málaga, EspagneRegional University Hospital of MalagaRecrute dans ce centre
  • Seville, EspagneUniversity Hospital Virgen del Rocio (HUVR)Recrute dans ce centre
  • Barcelona, EspagneHospital Quiron Dexeus BarcelonaRecrute dans ce centre
  • Barcelona, EspagneHospital Clinic of BarcelonaRecrute dans ce centre
  • Santiago de Compostela, EspagneUniversity Hospital Complex of Santiago (CHUS)Recrute dans ce centre
  • Girona, EspagneUniversity Hospital of Girona Dr. Josep TruetaRecrute dans ce centre

Au total, dans le monde, les 36 centres listés au registre recrutent.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 26 octobre 2026).

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

+ 6 autres lieux

Autres identifiants

  • 2024-516794-70-00 · n° CTIS

Voir aussi

Autres versions

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