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

Fujian Provincial Cancer Hospital

Status and phase: Unknown; Phase 3

Conditions: EGFR Gene Mutation

Treatments: Drug: cisplatin; Drug: Erlotinib; Drug: pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02886195

secgolc001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• EGFR mutation-negative
• Previous systemic antitumour treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

PC plus erlotinib

Experimental group

Description:

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

Treatment:

Drug: Erlotinib

Drug: pemetrexed

Drug: cisplatin

erlotinib

Active Comparator group

Description:

erlotinib 150mg/d until "progress disease"

Treatment:

Drug: Erlotinib

PC

Active Comparator group

Description:

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

Treatment:

Drug: pemetrexed

Drug: cisplatin