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

NCT ID: NCT02886195

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-07-31

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.

Conditions

EGFR Gene Mutation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

pemetrexed

Intervention Type: DRUG

500mg/m2 ivgtt d1, per three weeks

cisplatin

Intervention Type: DRUG

80mg/m2 ivgtt d1, per three weeks

Erlotinib

Intervention Type: DRUG

150mg po. every day

erlotinib

erlotinib 150mg/d until "progress disease"

Group Type: ACTIVE_COMPARATOR

Erlotinib

Intervention Type: DRUG

150mg po. every day

PC

pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles

Group Type: ACTIVE_COMPARATOR

pemetrexed

Intervention Type: DRUG

500mg/m2 ivgtt d1, per three weeks

cisplatin

Intervention Type: DRUG

80mg/m2 ivgtt d1, per three weeks

Interventions

pemetrexed

500mg/m2 ivgtt d1, per three weeks

Intervention Type: DRUG

cisplatin

80mg/m2 ivgtt d1, per three weeks

Intervention Type: DRUG

Erlotinib

150mg po. every day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Stage Ⅳ EGFR mutation-positive NSCLC
• Initial therapy
• ECOG performance status 0-1

Exclusion Criteria

• EGFR mutation-negative
• Previous systemic antitumour treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhiyong he he, master

Role: STUDY_CHAIR

Fujian province cancer hospital

References

Lin J, Li M, Chen S, Weng L, He Z. Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naive Advanced Non-Small-Cell Lung Cancer Patients Harboring Sensitive EGFR Mutations: A Single-Center, Open-Label, Single-Arm, Phase II Clinical Trial. J Inflamm Res. 2021 Jun 16;14:2557-2567. doi: 10.2147/JIR.S313056. eCollection 2021.

Reference Type: DERIVED

PMID: 34168480 (View on PubMed)

Other Identifiers

secgolc001

Identifier Type: -

Identifier Source: org_study_id