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

October 4, 2023 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of severe neutropenia (SN)
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of severe neutropenia (SN)
during Trilaciclib plus chemotherapy assessed up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of grade 3 and 4 hematologic toxicity
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of intravenous or oral antibiotic administration in treatment
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of G-CSF treatment
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of red blood cell (RBC) transfusions at or after week 5
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of ESA administration in treatment
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of TPO administration in treatment
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of platelet transfusion
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
The number and frequency of all-caused chemotherapy drugs reduction
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
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 )
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of infectious serious adverse events
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of pulmonary infection serious adverse events
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of febrile neutropenia
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Objective response rate
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
duration of response
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Progression-free survival time
Time Frame: during Trilaciclib plus chemotherapy assessed up to 6 months
during Trilaciclib plus chemotherapy assessed up to 6 months
Disease control rate
Time Frame: during chemotherapy assessed up to 6 months
during chemotherapy assessed up to 6 months
verall survival
Time Frame: maximun up to 1.5 years
maximun up to 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
G1 Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yongxing Chen, Hainan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings