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Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

Phase 4
Recruiting
Conditions
Extensive-stage Small-cell Lung Cancer
Interventions
Registration Number
NCT05874401
Lead Sponsor
Pharmacosmos A/S
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
302
Inclusion Criteria
  1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
  2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
  3. Measurable or evaluable disease as defined by RECIST v1.1
Exclusion Criteria
  1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
  2. 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
  3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
  4. Radiotherapy within 2 weeks
  5. History of ILD/pneumonitis
  6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo + Topotecan 1.5 mg/m²PlaceboPatients 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).
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²TopotecanPatients 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)
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²TrilaciclibPatients 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)
Placebo + Topotecan 1.5 mg/m²TopotecanPatients 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).
Primary Outcome Measures
NameTimeMethod
Overall survival (OS)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

Secondary Outcome Measures
NameTimeMethod
RBC related myeloprotection efficacyFrom date of randomization until end of Week 5

RBC transfusions on or after Week 5 (number of transfusions)

Platelet related myeloprotection efficacyFrom 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)

Chemotherapy dosingFrom 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.

Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAEFrom 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

Anti-tumor efficacyFrom 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

Neutrophil-related myeloprotection efficacyFrom date of randomization until end of treatment, assessed up to 52 months

Occurrence of G-CSF administration

Myeloprotection efficacyFrom date of randomization until end of treatment, assessed up to 52 months

Number of hospitalizations due to chemotherapy-induced myelosuppression

Trial Locations

Locations (1)

Hospital

🇪🇸

Seville, Spain

Hospital
🇪🇸Seville, Spain
MD, MD
Contact

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