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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

Primary Purpose

Extensive-stage Small-cell Lung Cancer

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Trilaciclib

About this trial

This is an interventional treatment trial for Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hainan General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trilaciclib, carboplatin, etoposide, Topotecan

Arm Description

Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients)

Outcomes

Primary Outcome Measures

Incidence of severe neutropenia (SN)

Secondary Outcome Measures

Incidence of grade 3 and 4 hematologic toxicity

Incidence of intravenous or oral antibiotic administration in treatment

Incidence of G-CSF treatment

Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time

Incidence of red blood cell (RBC) transfusions at or after week 5

The incidence of ESA administration in treatment

The incidence of TPO administration in treatment

The incidence of platelet transfusion

The number and frequency of all-caused chemotherapy drugs reduction

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 )

Incidence of infectious serious adverse events

Incidence of pulmonary infection serious adverse events

The incidence of febrile neutropenia

Objective response rate

duration of response

Progression-free survival time

Disease control rate

verall survival

Full Information

NCT ID

NCT05071703

First Posted

September 28, 2021

Last Updated

October 4, 2023

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

G1 Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05071703

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 11, 2021 (Actual)

Primary Completion Date

April 10, 2022 (Actual)

Study Completion Date

November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

G1 Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extensive-stage Small-cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trilaciclib, carboplatin, etoposide, Topotecan

Arm Type

Experimental

Arm Description

Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients)

Intervention Type

Drug

Intervention Name(s)

Trilaciclib

Other Intervention Name(s)

Trilaciclib, carboplatin, etoposide#or Topotecan

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of severe neutropenia (SN)

Description

Incidence of severe neutropenia (SN)

Time Frame