Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501976
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-29
Brief Title:
An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat locally-advanced SCLC after first-line therapy This study will enroll patients with thoracic disease but no distant metastases after first line treatment failure Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid DNA of tumor cells which is similar to the way radiation kills tumor cells Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC but the combination is always toxic This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects
Detailed Description:
PRIMARY OBJECTIVE
To describe the safety in terms of radiation therapy RT in combination with lurbinectedin in patients with locally-advanced SCLC after first-line therapy
SECONDARY OBJECTIVES
To evaluate the preliminary efficacy of RT plus lurbinectedin as assessed by Progression free survival PFS and Overall survival OS
OUTLINE
Patients receive 2 cycles of lurbinectedin combined with thoracic radiotherapy followed by 2 cycles of lurbinectedin alone Patients receive lurbinectedin intravenously IV over 1 hour on day 1 of each cycle G-CSFGranulocyte Colony-Stimulating Factor will be used for prophylaxis
To describe the safety in terms of radiation therapy RT in combination with lurbinectedin in patients with locally-advanced SCLC after first-line therapy
SECONDARY OBJECTIVES
To evaluate the preliminary efficacy of RT plus lurbinectedin as assessed by Progression free survival PFS and Overall survival OS
OUTLINE
Patients receive 2 cycles of lurbinectedin combined with thoracic radiotherapy followed by 2 cycles of lurbinectedin alone Patients receive lurbinectedin intravenously IV over 1 hour on day 1 of each cycle G-CSFGranulocyte Colony-Stimulating Factor will be used for prophylaxis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None