Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation

November 28, 2013 updated by: li shan, Xinjiang Medical University

A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation

This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Locations

  • China
    • Xinjiang
      • Urumqi, Xinjiang, China, XJTHLC001
        • Xinjiang Medical University

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:

  • adult patients, >=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.

Exclusion Criteria:

  • prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.

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 combine with chemotherapy
Drug: gemcitabine 1000mg/m2 iv on days 1 of each 4 week cycle for 6 cycles Drug: Platinum chemotherapy (cisplatin or carboplatin) cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles Drug: Erlotinib[Tarceva] po on days 15-28 of each 4 week cycle until disease progression
Drug: gemcitabine; cisplatin or carboplatin; erlotinib
Other Names:
  • tarceva
Active Comparator: erlotinib along
Drug: erlotinib [Tarceva] 150mg/day po until disease progression
Drug: erlotinib
Other Names:
  • tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 24 mont
From date of randomization until the date of death from any cause, assessed up to 24 mont

Collaborators and Investigators

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

Sponsor

Xinjiang 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

December 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 28, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

November 28, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTHLC001

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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