NCT07099898Recrutement en cours
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
Résumé
In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.
Critères d'inclusion
Participants are eligible to be included in the study only if all of the following criteria apply: • Adults \>18 or the minimum legal adult age at the time the informed consent form is signed • Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). • Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible. • Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. • Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol. • Has adequate organ function and an ECOG performance status of 0 or 1
Critères d'exclusion
Participants are excluded from the study if any of the following criteria apply: • Pathological diagnosis of complex SCLC or transformed SCLC. • Limited stage small cell lung cancer at diagnosis • Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3. • Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. • Has severe, uncontrolled or active cardiovascular disorders. • Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. • Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV). • Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases. • Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids. • Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease), • Has active Hepatitis B or Hepatitis C
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, Italie, États-Unis, Argentine, Australie, Brésil, Bulgarie, Canada, Finlande, Grèce, Hongrie, Irlande, Israël, Japon, Mexique, Pologne, Portugal, Roumanie, Corée du Sud, Espagne, Suède, Turquie, Royaume-Uni
- Promoteur
- GlaxoSmithKline(Industrie)
- N° de protocole
- 223674
- Pathologies
- Neoplasms, Lung
- Interventions
- Biologique, Médicament
Traitements évalués
- Risvutatug rezetecan (Ris-Rez)
- Topotecan
Lieux · 141
- Basel, SuisseGSK Investigational SiteRecrute dans ce centre
- Lausanne, SuisseGSK Investigational SiteRecrute dans ce centre
- Boulogne-Billancourt, FranceGSK Investigational SiteRecrute dans ce centre
- Grenoble, FranceGSK Investigational SiteRecrute dans ce centre
- Saint-Herblain, FranceGSK Investigational SiteRecrute dans ce centre
- Villejuif, FranceGSK Investigational SiteRecrute dans ce centre
- Karlsruhe, AllemagneGSK Investigational SiteRecrute dans ce centre
- Löwenstein, AllemagneGSK Investigational SiteRecrute dans ce centre
- Stuttgart, AllemagneGSK Investigational SiteRecrute dans ce centre
- Augsburg, AllemagneGSK Investigational SiteRecrute dans ce centre
- Chemnitz, AllemagneGSK Investigational SiteRecrute dans ce centre
- Esslingen am Neckar, AllemagneGSK Investigational SiteRecrute dans ce centre
- Heidelberg, AllemagneGSK Investigational SiteRecrute dans ce centre
- Immenhausen, AllemagneGSK Investigational SiteRecrute dans ce centre
- Lübeck, AllemagneGSK Investigational SiteRecrute dans ce centre
- München, AllemagneGSK Investigational SiteRecrute dans ce centre
- Nuremberg, AllemagneGSK Investigational SiteRecrute dans ce centre
- Milan, ItalieGSK Investigational SiteRecrute dans ce centre
- Bergamo, ItalieGSK Investigational SiteRecrute dans ce centre
- Genova, ItalieGSK Investigational SiteRecrute dans ce centre
- Orbassano, ItalieGSK Investigational SiteRecrute dans ce centre
- Pisa, ItalieGSK Investigational SiteRecrute dans ce centre
- Roma, ItalieGSK Investigational SiteRecrute dans ce centre
- Siena, ItalieGSK Investigational SiteRecrute dans ce centre
- Verona, ItalieGSK Investigational SiteRecrute dans ce centre
- Los Angeles, États-UnisGSK Investigational SiteRecrute dans ce centre
- Miami, États-UnisGSK Investigational SiteRecrute dans ce centre
- Plantation, États-UnisGSK Investigational SiteRecrute dans ce centre
- Tamarac, États-UnisGSK Investigational SiteRecrute dans ce centre
- East Syracuse, États-UnisGSK Investigational SiteRecrute dans ce centre
Au total, dans le monde, 141 des 144 centres listés au registre recrutent ; les 3 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 20 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 111 autres lieux
Autres identifiants
- 2025-521627-78-00 · n° CTIS
- 2025 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.