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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02886195
Acronym
effect
Enrollment
120
Registered
2016-09-01
Start date
2016-07-31
Completion date
2019-07-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Gene Mutation

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.

Interventions

DRUGpemetrexed

500mg/m2 ivgtt d1, per three weeks

DRUGcisplatin

80mg/m2 ivgtt d1, per three weeks

DRUGErlotinib

150mg po. every day

Sponsors

Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* EGFR mutation-negative * Previous systemic antitumour treatment

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS)6 months

Secondary

MeasureTime frameDescription
Response Rate (RR)2 months
Overall Survival (OS)6 months
Adverse Event (AE)2 monthsNCI CTC 4.03

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026