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

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.

Study Overview

• Status: Completed
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: Trilaciclib

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 100021
      • Hainan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Trilaciclib, carboplatin, etoposide#or Topotecan

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: G1 Therapeutics, Inc.
• Investigators: Principal Investigator: Yongxing Chen, Hainan General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Carboplatin; Etoposide; Topotecan
• Other Study ID Numbers: Trila-CN-RWS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes