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

NCT05071703 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Trila-CN-RWS-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of severe neutropenia (SN)

  Incidence of severe neutropenia (SN)

  during Trilaciclib plus chemotherapy assessed up to 6 months

Secondary Outcomes (18)

• 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

Study Arms (1)

Trilaciclib, carboplatin, etoposide, Topotecan

EXPERIMENTAL

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

Drug: Trilaciclib

Interventions

Trilaciclib DRUG

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

Also known as: Trilaciclib, carboplatin, etoposide#or Topotecan

Trilaciclib, carboplatin, etoposide, Topotecan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is currently participating in other Interventional clinical studies;

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• G1 Therapeutics, Inc.: collaborator

Study Sites (1)

Hainan General Hospital

Haikou, Hainan, 100021, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

trilaciclib; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Yongxing Chen

  Hainan General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: August 11, 2021
• Primary Completion: April 10, 2022
• Study Completion: November 30, 2022
• Last Updated: October 6, 2023

Record last verified: 2021-09

Locations

CN (1)