Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

February 11, 2015 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer

The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510120
        • Recruiting
        • Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • jianxing he, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histological diagnosis of NSCLC with phase IIIB or IV disease;
  2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
  3. Never received anti-tumor therapies for the advanced stage;
  4. Never used EGFR inhibitors;
  5. Measurable disease by RECIST criteria;
  6. Male or female patients >=18 years of age;
  7. ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
  8. Patients must be accessible for treatment and follow-up;

Exclusion Criteria:

  1. Previously used EGFR inhibitors
  2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
  3. Allergic to erlotinib;
  4. Non-measurable lesions
  5. Pregnant or lactating women;
  6. Patients having other factors that preventing researchers from enrollment them.

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: Erlotinib 100mg
Drug: Erlotinib
100mg vs. 150mg
Other Names:
  • tarceva
Active Comparator: Erlotinib 150mg
Drug: Erlotinib
100mg vs. 150mg
Other Names:
  • tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 2 years after the initial dose
2 years after the initial dose

Secondary Outcome Measures

Outcome Measure
Time Frame
The objective response rate
Time Frame: Patients will be followed for an expected average of 6 months
Patients will be followed for an expected average of 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 1 year
1 year
Overall survival
Time Frame: 3 year after the initial dose
3 year after the initial dose

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

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

August 1, 2013

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 5, 2013

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAHG20130819
  • GZMC201301

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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