- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02886195
EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC (effect)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stage Ⅳ EGFR mutation-positive NSCLC
- Initial therapy
- ECOG performance status 0-1
Exclusion Criteria:
- EGFR mutation-negative
- Previous systemic antitumour treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PC plus erlotinib
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy
|
500mg/m2 ivgtt d1, per three weeks
80mg/m2 ivgtt d1, per three weeks
150mg po. every day
|
Active Comparator: erlotinib
erlotinib 150mg/d until "progress disease"
|
150mg po. every day
|
Active Comparator: PC
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles
|
500mg/m2 ivgtt d1, per three weeks
80mg/m2 ivgtt d1, per three weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-Free Survival (PFS)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate (RR)
Time Frame: 2 months
|
2 months
|
|
Overall Survival (OS)
Time Frame: 6 months
|
6 months
|
|
Adverse Event (AE)
Time Frame: 2 months
|
NCI CTC 4.03
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: zhiyong he he, master, Fujian Province Cancer Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- secgolc001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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