Trilaciclib vs placebo hos pasienter med småcellet lungekreft i omfattende stadium (ES-SCLC) som får topotekan
En randomisert, dobbeltblind, placebokontrollert studie av Trilaciclib vs Placebo hos pasienter med omfattende småcellet lungekreft (ES-SCLC) som får topotecan kjemoterapi
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Seville, Spania
- Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
Andre navn:
Participants will receive intravenous topotecan infusion
Andre navn:
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Placebo komparator: 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
Andre navn:
Participants will receive intravenous placebo infusion |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anti-tumor efficacy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Pharmacosmos Clinical and non-clinical Department, Pharmacosmos A/S
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- G1T28-211
- 2022-502357-34-00 (Annen identifikator: EU-CTR)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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