EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

Study Overview
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Brief Summary
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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
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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.

Official Title
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EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

Conditions
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EGFR Gene Mutation

Intervention / Treatment
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* Drug: pemetrexed
* Drug: cisplatin
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage Ⅳ EGFR mutation-positive NSCLC Initial therapy ECOG performance status 0-1 Exclusion Criteria: EGFR mutation-negative Previous systemic antitumour treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PC plus erlotinib<br>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 | Drug: pemetrexed<br>* 500mg/m2 ivgtt d1, per three weeks<br>Drug: cisplatin<br>* 80mg/m2 ivgtt d1, per three weeks<br>Drug: Erlotinib<br>* 150mg po. every day<br>|
| Active Comparator: erlotinib<br>erlotinib 150mg/d until progress disease | Drug: Erlotinib<br>* 150mg po. every day<br>|
| Active Comparator: PC<br>pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles | Drug: pemetrexed<br>* 500mg/m2 ivgtt d1, per three weeks<br>Drug: cisplatin<br>* 80mg/m2 ivgtt d1, per three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (RR) |  | 2 months | 
| Overall Survival (OS) |  | 6 months | 
| Adverse Event (AE) | NCI CTC 4.03 | 2 months |