Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
- Registration Number
- NCT05071703
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief Summary
This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Voluntarily participate and sign informed consent;
- must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:
- Patients with extensive small-cell lung cancer confirmed by histology or cytology
- Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment
- Patient is currently participating in other Interventional clinical studies;
- Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trilaciclib, carboplatin, etoposide, Topotecan Trilaciclib Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients)
- Primary Outcome Measures
Name Time Method Incidence of severe neutropenia (SN) during Trilaciclib plus chemotherapy assessed up to 6 months Incidence of severe neutropenia (SN)
- Secondary Outcome Measures
Name Time Method The incidence of febrile neutropenia during Trilaciclib plus chemotherapy assessed up to 6 months Incidence of G-CSF treatment during Trilaciclib plus chemotherapy assessed up to 6 months The number and frequency of all-caused chemotherapy drugs reduction during Trilaciclib plus chemotherapy assessed up to 6 months Incidence of pulmonary infection serious adverse events during Trilaciclib plus chemotherapy assessed up to 6 months duration of response during Trilaciclib plus chemotherapy assessed up to 6 months Progression-free survival time during Trilaciclib plus chemotherapy assessed up to 6 months Incidence of grade 3 and 4 hematologic toxicity during Trilaciclib plus chemotherapy assessed up to 6 months Objective response rate during Trilaciclib plus chemotherapy assessed up to 6 months Disease control rate during chemotherapy assessed up to 6 months Incidence of red blood cell (RBC) transfusions at or after week 5 during Trilaciclib plus chemotherapy assessed up to 6 months The incidence of platelet transfusion during Trilaciclib plus chemotherapy assessed up to 6 months Incidence of intravenous or oral antibiotic administration in treatment during Trilaciclib plus chemotherapy assessed up to 6 months Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time during Trilaciclib plus chemotherapy assessed up to 6 months The incidence of ESA administration in treatment during Trilaciclib plus chemotherapy assessed up to 6 months composite end point - Significant hematologic adverse event (occurrence of any of the following events：all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia ) during Trilaciclib plus chemotherapy assessed up to 6 months Incidence of infectious serious adverse events during Trilaciclib plus chemotherapy assessed up to 6 months The incidence of TPO administration in treatment during Trilaciclib plus chemotherapy assessed up to 6 months verall survival maximun up to 1.5 years
Trial Locations
- Locations (1)
Hainan General Hospital
🇨🇳Haikou, Hainan, China