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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Extensive-stage Small-cell Lung Cancer

Intervention / Treatment
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* Drug: Trilaciclib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trilaciclib, carboplatin, etoposide, Topotecan<br>Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients) | Drug: Trilaciclib<br>* Carboplatin combined with Etoposide (ES-SCLC patients) plus Topotecan (second/third line ES-SCLC patients)<br>* Other names: Trilaciclib, carboplatin, etoposide#or Topotecan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe neutropenia (SN) | Incidence of severe neutropenia (SN) | during Trilaciclib plus chemotherapy assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |