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

August 27, 2016 updated by: Fujian Cancer Hospital
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: pemetrexed
500mg/m2 ivgtt d1, per three weeks
Drug: cisplatin
80mg/m2 ivgtt d1, per three weeks
Drug: Erlotinib
150mg po. every day
Active Comparator: erlotinib
erlotinib 150mg/d until "progress disease"
Drug: Erlotinib
150mg po. every day
Active Comparator: PC
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles
Drug: pemetrexed
500mg/m2 ivgtt d1, per three weeks
Drug: cisplatin
80mg/m2 ivgtt d1, per three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (RR)
Time Frame: 2 months
2 months
Overall Survival (OS)
Time Frame: 6 months
6 months
Adverse Event (AE)
Time Frame: 2 months
NCI CTC 4.03
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Investigators

  • Study Chair: zhiyong he he, master, Fujian Province Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 27, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • secgolc001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Depending on the process of the study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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