Extensive-stage Small-cell Lung Cancer
Conditions
Keywords
myelosuppression, ES-SCLC, chemotherapy-induced myelosuppression, chemotherapy-induced neutropenia, chemotherapy-induced anemia, myeloprotection
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.
Interventions
DRUGTrilaciclib
Participants will receive intravenous trilaciclib infusion
DRUGPlacebo
Participants will receive intravenous placebo infusion
DRUGTopotecan
Participants will receive intravenous topotecan infusion
Sponsors
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil-related myeloprotection efficacy | From date of randomization until end of cycle 1 (each cycle is 21 days) | Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1 |
| RBC related myeloprotection efficacy | 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 |
| Platelet related myeloprotection efficacy | 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) |
| Anti-tumor efficacy | 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 |
| Chemotherapy dosing | 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. |
| Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE | 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 |
| Myeloprotection efficacy | From date of randomization until end of treatment, assessed up to 52 months | Occurrence of hospitalizations due to chemotherapy-induced myelosuppression |
Countries
Spain
Contacts
Primary ContactPharmacosmos Clinical and non-clinical Department
Outcome results
None listed