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.
This is a single-arm, exploratory clinical study. Eligible patients were treated with Trilaciclib before the first cycle of chemotherapy, and their peripheral blood samples were tested on days 3,7,14,21±1 after chemotherapy. At the same time, the incidence of FN, the use of antibiotics, the safety, the number of patients who delayed the second cycle of treatment, the number of patients who reduced the dose of chemotherapy, the number of patients who reduced the dose of chemotherapy due to neutropenia, and the number of patients who discontinued chemotherapy were observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Patients with lung adenocarcinoma were given Trilaciclib combined with pemetrexed and carboplatin, Q3W; For patients with lung squamous cell carcinoma,Trilaciclib combined with paclitaxel/albumin-bound paclitaxel and carboplatin, Q3W. From cycle 2 onwards, patients chose whether to use trasylol with chemotherapy.
Taixing People's Hospital
Taishing, Jiangsu, China
RECRUITINGIncidence of febrile neutropenia (FN)
Incidence of febrile neutropenia in the first treatment cycle
Time frame: during Trilaciclib plus chemotherapy assessed up to 21 days
Incidence of Treatment-Emergent Adverse Events
Occurrence and severity of AEs by NCI CTCAE v5.0
Time frame: Up to 2 years
Antibiotic Use rate
Antibiotic Use rate in the first treatment cycle
Time frame: during Trilaciclib plus chemotherapy assessed up to 21 days
Number of medication delays
Number of delays in the second treatment cycle due to myelosuppression
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Number of chemotherapy dose reductions
Number of chemotherapy dose reductions in the second treatment cycle due to myelosuppression
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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