A phase III, randomised, double-blind, placebo-controlled, multicentre trial comparing efficacy and safety of trilaciclib versus placebo in participants with limited-stage small cell lung cancer

Limited-stage small cell lung cancer (LS-SCLC)

• Duration of severe neutropenia in cycle 1, • Occurrence of severe neutropenia

Efficacy • Number of all-cause chemotherapy dose reductions, • Occurrence of granulocyte colony-stimulatingfactor (G-CSF) administration, • Number of hospitalisations due to myelosuppression or sepsis, • Number of febrile neutropenia (grade 3 or 4), • Occurrence of red blood cell (RBC) transfusions on/after week 5, • ORR per response evaluation criteria in solid tumours (RECIST) guideline version 1.1, • BOR per RECIST guideline version 1.1, • Duration of severe neutropenia in cycle 2, • Duration of severe neutropenia in cycle 2 through 4, • Number of all-cause interruptions of radiotherapy, • Occurrence of radiotherapy-induced toxicities mucositis and/or esophagitis, • Occurrence of all-cause chemotherapy dose reductions, • Number of chemotherapy dose reductions in cycle 4, • Occurrence of all-cause cycle delays, • Number of all-cause cycle delays, • Occurrence of hospitalisations due to myelosuppression or sepsis, • Occurrence of febrile neutropenia (grade 3 or 4), • Occurrence of grade 3 or 4 haematologic toxicities (absolute neutrophil count [ANC], haemoglobin [Hb], and platelet counts), • Occurrence of platelet transfusions, • Occurrence of erythropoiesis-stimulating agent (ESA) administrations, • Occurrence of systemic antimicrobial therapy, • Change in Functional Assessment of Cancer Therapy-Lung (FACT-L, total score, subscale domains, and Trial Outcome Index [TOI]) from baseline to day 1 of cycles 2–4, days 10 and 17 of each cycle, end-of-treatment, and follow-up at day 90, • Time to deterioration in FACT-L total score, subscale domains, and TOI, • Change in Functional Assessment of Cancer Therapy-Anaemia (FACT-An, total score, subscale domains, and TOI) from baseline to day 1 of cycles 2–4, days 10 and 17 of each cycle, end-of-treatment, and follow-up at day 90, • Time to deterioration in FACT-An total score, subscale domains, and TOI, Safety • Type and occurrence of adverse events (AEs), • Type and occurrence of adverse events of safety focus area (AESFA), • Time from baseline to onset of first AESFA, • Time from last trilaciclib dose to onset of any AESFA, • Duration of AESFA, • Occurrence of grade 3 or 4 clinical chemistry toxicities, • Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, vital signs, weight, electrocardiogram (ECG), and safety laboratory tests will be measured as part of standard safety assessments

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