Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Trial Parameters
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.
Eligibility Criteria
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