Trilaciclib vs placebo chez des patients atteints d'un cancer du poumon à petites cellules au stade étendu (ES-SCLC) recevant du topotécan
Une étude randomisée, en double aveugle et contrôlée par placebo comparant le trilaciclib à un placebo chez des patients atteints d'un cancer du poumon à petites cellules au stade étendu (ES-SCLC) recevant une chimiothérapie au topotécan
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Seville, Espagne
- Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
- Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
- Measurable or evaluable disease as defined by RECIST v1.1
Exclusion Criteria:
- History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
- Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
- Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
- Radiotherapy within 2 weeks
- History of ILD/pneumonitis
- History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²) |
Participants will receive intravenous trilaciclib infusion
Autres noms:
Participants will receive intravenous topotecan infusion
Autres noms:
|
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Comparateur placebo: Placebo + Topotecan 1.5 mg/m²
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²). |
Participants will receive intravenous topotecan infusion
Autres noms:
Participants will receive intravenous placebo infusion |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival (OS)
Délai: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
|
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan |
From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anti-tumor efficacy
Délai: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
|
To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan |
From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
|
|
Anti-tumor efficacy
Délai: From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
|
To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan |
From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
|
|
Anti-tumor efficacy
Délai: From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
|
To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan |
From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
|
|
Neutrophil-related myeloprotection efficacy
Délai: From date of randomization until end of cycle 1 (each cycle is 21 days)
|
Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1 |
From date of randomization until end of cycle 1 (each cycle is 21 days)
|
|
Neutrophil-related myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Neutrophil-related myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of G-CSF administration |
From date of randomization until end of treatment, assessed up to 52 months
|
|
RBC related myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration |
From date of randomization until end of treatment, assessed up to 52 months
|
|
RBC related myeloprotection efficacy
Délai: From date of randomization until end of Week 5
|
RBC transfusions on or after Week 5 (occurrence) |
From date of randomization until end of Week 5
|
|
RBC related myeloprotection efficacy
Délai: From date of randomization until end of Week 5
|
RBC transfusions on or after Week 5 (number of transfusions) |
From date of randomization until end of Week 5
|
|
Platelet related myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence) |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Platelet related myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions) |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Myeloprotection efficacy
Délai: From date of randomization until end of treatment, assessed up to 52 months
|
Number of hospitalizations due to chemotherapy-induced myelosuppression |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Chemotherapy dosing
Délai: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan. |
From the date of randomization until end of treatment, assessed up to 52 months
|
|
Chemotherapy dosing
Délai: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan. |
From the date of randomization until end of treatment, assessed up to 52 months
|
|
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
Délai: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest |
From the date of randomization until end of treatment, assessed up to 52 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pharmacosmos Clinical and non-clinical Department, Pharmacosmos A/S
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Maladies pulmonaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Carcinome bronchique
- Tumeurs bronchiques
- Carcinome pulmonaire à petites cellules
- Composés hétérocycliques
- Camptothécine
- Alcaloïdes
- Topotécan
- trilaciclib
Autres numéros d'identification d'étude
- G1T28-211
- 2022-502357-34-00 (Autre identifiant: EU-CTR)
Informations sur les médicaments et les dispositifs, documents d'étude
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