A Prospective, Single-arm, Exploratory Clinical Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer
The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.
• Age above 18 years old (including 18 years old)，regardless of gender；
• ECOG-PS score of 0-1,；
• expected survival≥12 weeks；
• There was no tumor deterioration in the 2 weeks prior to study drug treatment.
• Advanced non-small cell lung cancer without systemic chemotherapy.
• At least one tumor lesion with a maximum diameter ≥10 mm (short diameter ≥15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose.
• Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment.
• Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment.
• All subjects voluntarily participated and signed the informed consent form in person.