Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-30 @ 9:11 AM
Study NCT ID:
NCT05071703
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: