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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trilaciclib, carboplatin, etoposide, Topotecan Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients) |
Drug: Trilaciclib
Carboplatin combined with Etoposide (ES-SCLC patients)
plus Topotecan (second/third line ES-SCLC patients)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of severe neutropenia (SN) [during Trilaciclib plus chemotherapy assessed up to 6 months]
Incidence of severe neutropenia (SN)
Secondary Outcome Measures
- Incidence of grade 3 and 4 hematologic toxicity [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]
- Incidence of G-CSF 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]
- Incidence of red blood cell (RBC) transfusions at or after week 5 [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]
- The incidence of TPO administration in treatment [during Trilaciclib plus chemotherapy assessed up to 6 months]
- The incidence of platelet transfusion [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]
- 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]
- Incidence of pulmonary infection serious adverse events [during Trilaciclib plus chemotherapy assessed up to 6 months]
- The incidence of febrile neutropenia [during Trilaciclib plus chemotherapy assessed up to 6 months]
- Objective response rate [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]
- Disease control rate [during chemotherapy assessed up to 6 months]
- verall survival [maximun up to 1.5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hainan General Hospital | Haikou | Hainan | China | 100021 |
Sponsors and Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- G1 Therapeutics, Inc.
Investigators
- Principal Investigator: Yongxing Chen, Hainan General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Trila-CN-RWS-001