NSCLC
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Taixing People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); * stroke or cardio-cerebrovascular event within 6 months before enrollment; * QTcF interval \> 480msec at screening or \> 500msec for patients with implanted ventricular pacemakers; * Previous hematopoietic stem cell or bone marrow transplantation; * Allergy to the study drug or its components; * Others considered by the investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia (FN) | during Trilaciclib plus chemotherapy assessed up to 21 days | Incidence of febrile neutropenia in the first treatment cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to 2 years | Occurrence and severity of AEs by NCI CTCAE v5.0 |
| Antibiotic Use rate | during Trilaciclib plus chemotherapy assessed up to 21 days | Antibiotic Use rate in the first treatment cycle |
| Number of medication delays | At the end of Cycle 1 (each cycle is 28 days) | Number of delays in the second treatment cycle due to myelosuppression |
| Number of chemotherapy dose reductions | At the end of Cycle 1 (each cycle is 28 days) | Number of chemotherapy dose reductions in the second treatment cycle due to myelosuppression |
Countries
China
Contacts
Primary Contactliu C yang, M.D.
Outcome results
None listed