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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilaciclib plus chemotherapy | Experimental | Patients with lung adenocarcinoma were treated with Trilaciclib (240mg/m2, d1, within 4 hours before each chemotherapy) combined with pemetrexed and carboplatin (dose according to the guideline recommendation, d1, Q3W). "For squamous lung cancer, Trilaciclib (d1, 240mg/m2, 4 hours before each chemotherapy) plus paclitaxel/albumin-bound paclitaxel plus carboplatin (dose according to guideline recommendation, d1), Q3W." In the second cycle, patients were left to their own discretion with or without treaclib combination therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilaciclib Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia (FN) | Incidence of febrile neutropenia in the first treatment cycle | during Trilaciclib plus chemotherapy assessed up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Occurrence and severity of AEs by NCI CTCAE v5.0 | Up to 2 years |
| Antibiotic Use rate | Antibiotic Use rate in the first treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liu C yang, M.D. | Contact | 87656001 | 0523 | liuyctx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| liu C yang, M.D. | Taixing People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taixing People's Hospital | Recruiting | Taishing | Jiangsu | 225400 | China |
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| ID | Term |
|---|---|
| C000708352 | trilaciclib |
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| during Trilaciclib plus chemotherapy assessed up to 21 days |
| Number of medication delays | Number of delays in the second treatment cycle due to myelosuppression | 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 | At the end of Cycle 1 (each cycle is 28 days) |