Trilaciclib vs placebo u pacientů s rozsáhlým stadiem malobuněčného karcinomu plic (ES-SCLC), kteří dostávají topotekan
Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie trilaciclibu vs. placebo u pacientů s rozsáhlým stádiem malobuněčného karcinomu plic (ES-SCLC) léčených topotekanem
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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Seville, Španělsko
- Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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
Ostatní jména:
Participants will receive intravenous topotecan infusion
Ostatní jména:
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Komparátor placeba: 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
Ostatní jména:
Participants will receive intravenous placebo infusion |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall survival (OS)
Časové okno: 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
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Anti-tumor efficacy
Časové okno: 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
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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
|
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Anti-tumor efficacy
Časové okno: 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
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Anti-tumor efficacy
Časové okno: 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
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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
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Neutrophil-related myeloprotection efficacy
Časové okno: From date of randomization until end of cycle 1 (each cycle is 21 days)
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Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1 |
From date of randomization until end of cycle 1 (each cycle is 21 days)
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Neutrophil-related myeloprotection efficacy
Časové okno: From date of randomization until end of treatment, assessed up to 52 months
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Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs |
From date of randomization until end of treatment, assessed up to 52 months
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Neutrophil-related myeloprotection efficacy
Časové okno: From date of randomization until end of treatment, assessed up to 52 months
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Occurrence of G-CSF administration |
From date of randomization until end of treatment, assessed up to 52 months
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RBC related myeloprotection efficacy
Časové okno: 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
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RBC related myeloprotection efficacy
Časové okno: From date of randomization until end of Week 5
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RBC transfusions on or after Week 5 (occurrence) |
From date of randomization until end of Week 5
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RBC related myeloprotection efficacy
Časové okno: From date of randomization until end of Week 5
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RBC transfusions on or after Week 5 (number of transfusions) |
From date of randomization until end of Week 5
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Platelet related myeloprotection efficacy
Časové okno: From date of randomization until end of treatment, assessed up to 52 months
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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
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Platelet related myeloprotection efficacy
Časové okno: 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
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Myeloprotection efficacy
Časové okno: 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
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Myeloprotection efficacy
Časové okno: 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
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Chemotherapy dosing
Časové okno: 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
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Chemotherapy dosing
Časové okno: 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
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Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
Časové okno: From the date of randomization until end of treatment, assessed up to 52 months
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pharmacosmos Clinical and non-clinical Department, Pharmacosmos A/S
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- G1T28-211
- 2022-502357-34-00 (Jiný identifikátor: EU-CTR)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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