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

NCT ID: NCT05071703

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2022-11-30

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trilaciclib, carboplatin, etoposide, Topotecan

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

Group Type: EXPERIMENTAL

Trilaciclib

Intervention Type: DRUG

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

Interventions

Trilaciclib

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

Intervention Type: DRUG

Other Intervention Names

Trilaciclib, carboplatin, etoposide#or Topotecan

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G1 Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongxing Chen

Role: PRINCIPAL_INVESTIGATOR

Hainan General Hospital

Locations

Hainan General Hospital

Haikou, Hainan, China

Countries

China

Other Identifiers

Trila-CN-RWS-001

Identifier Type: -

Identifier Source: org_study_id