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

EGFR Gene Mutation Clinical Trial

— effect  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02886195
• Other study ID #: secgolc001
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: August 2, 2016
• Last updated: August 27, 2016
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: July 2016
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stage ? EGFR mutation-positive NSCLC

• Initial therapy

• ECOG performance status 0-1

Exclusion Criteria:

• EGFR mutation-negative

• Previous systemic antitumour treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• EGFR Gene Mutation

Intervention

Drug:
• pemetrexed
500mg/m2 ivgtt d1, per three weeks
• cisplatin
80mg/m2 ivgtt d1, per three weeks
• Erlotinib
150mg po. every day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)		6 months	No
Secondary	Response Rate (RR)		2 months	No
Secondary	Overall Survival (OS)		6 months	No
Secondary	Adverse Event (AE)	NCI CTC 4.03	2 months	Yes