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

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071703
• Other study ID #: Trila-CN-RWS-001
• Status: Completed
• Phase: Phase 4
• Start date: August 11, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: September 2021
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2022
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Voluntarily participate and sign informed consent;

2. must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:

3. Patients with extensive small-cell lung cancer confirmed by histology or cytology

4. Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment

Exclusion Criteria:

1. Patient is currently participating in other Interventional clinical studies;

2. Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Trilaciclib
Carboplatin combined with Etoposide (ES-SCLC patients) plus Topotecan (second/third line ES-SCLC patients)

Locations

Country	Name	City	State
China	Hainan General Hospital	Haikou	Hainan

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.	G1 Therapeutics, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe neutropenia (SN)	Incidence of severe neutropenia (SN)	during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Incidence of grade 3 and 4 hematologic toxicity		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Incidence of intravenous or oral antibiotic administration in treatment		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Incidence of G-CSF treatment		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Incidence of red blood cell (RBC) transfusions at or after week 5		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	The incidence of ESA administration in treatment		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	The incidence of TPO administration in treatment		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	The incidence of platelet transfusion		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	The number and frequency of all-caused chemotherapy drugs reduction		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	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
Secondary	Incidence of infectious serious adverse events		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Incidence of pulmonary infection serious adverse events		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	The incidence of febrile neutropenia		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Objective response rate		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	duration of response		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Progression-free survival time		during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary	Disease control rate		during chemotherapy assessed up to 6 months
Secondary	verall survival		maximun up to 1.5 years