Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-20 @ 11:07 AM
Study NCT ID:
NCT02886195
Status:
UNKNOWN
Last Update Posted:
2016-09-01
First Post:
2016-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
Sponsor:
Fujian Cancer Hospital
Organization:
Study Overview
Official Title:
EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ENROLLING_BY_INVITATION
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:
effect
Brief Summary:
The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).
Detailed Description:
This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).
Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.
The endpoint of this study included clinical efficacy and safety.
Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.
The endpoint of this study included clinical efficacy and safety.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: