Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT03046316
Status:
RECRUITING
Last Update Posted:
2020-07-23
First Post:
2016-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
Sponsor:
Guangdong Association of Clinical Trials
Organization:
Study Overview
Official Title:
Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
Status:
RECRUITING
Status Verified Date:
2020-07
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:
LOCAL
Brief Summary:
This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).
Detailed Description:
It is required that pathological diagnosis and genetic profile including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) be established prior to enrollment. Standard front line systemic should be given according to clinical practice. Molecular targeting drugs for patients with driving mutations should be acquired legally. Patients without driving mutations should undergo standard first line chemotherapy and or immunological checkpoint inhibitors. One cycle is three weeks and response evaluation is done every two cycles. CR, PR and SD should be confirmed after four cycles of therapy.
Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.
Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: