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

Phase 3

• Conditions: EGFR Gene Mutation
• Interventions: Drug: pemetrexed; Drug: cisplatin; Drug: Erlotinib

• Registration Number: NCT02886195
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-27
• Last Update Submitted: 2016-08-27
• Study First Posted: 2016-09-01
• Last Update Posted: 2016-09-01
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PC plus erlotinib	pemetrexed	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
PC plus erlotinib	cisplatin	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
PC plus erlotinib	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
erlotinib	Erlotinib	erlotinib 150mg/d until "progress disease"
PC	pemetrexed	pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles
PC	cisplatin	pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	6 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	6 months
Adverse Event (AE)	2 months	NCI CTC 4.03
Response Rate (RR)	2 months