Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trilaciclib, Placebo, Topotecan.
- Who it may be relevant to
- Registry conditions: Extensive-stage Small-cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
Overview
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.
Interventions
- Drug Trilaciclib
Participants will receive intravenous trilaciclib infusion - Drug Placebo
Participants will receive intravenous placebo infusion - Drug Topotecan
Participants will receive intravenous topotecan infusion
Primary outcome measures
- Overall survival (OS) [Time frame: 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]
Secondary outcome measures (12)
- Anti-tumor efficacy [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From date of randomization until end of cycle 1 (each cycle is 21 days)]
- Neutrophil-related myeloprotection efficacy [Time frame: From date of randomization until end of treatment, assessed up to 52 months]
- Neutrophil-related myeloprotection efficacy [Time frame: From date of randomization until end of treatment, assessed up to 52 months]
- RBC related myeloprotection efficacy [Time frame: From date of randomization until end of treatment, assessed up to 52 months]
- RBC related myeloprotection efficacy [Time frame: From date of randomization until end of Week 5]
- RBC related myeloprotection efficacy [Time frame: From date of randomization until end of Week 5]
- Platelet related myeloprotection efficacy [Time frame: From date of randomization until end of treatment, assessed up to 52 months]
- Platelet related myeloprotection efficacy [Time frame: From date of randomization until end of treatment, assessed up to 52 months]
- Myeloprotection efficacy [Time frame: From date of randomization until end of treatment, assessed up to 52 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital — Seville
Identifiers
NCT: NCT05874401 · G1T28-211 · 2022-502357-34-00