Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

September 11, 2014 updated by: Si-Yu Wang

A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma

Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed Lung adenocarcinoma
  • Wld-type EGFR
  • Stage IIIB/IV
  • Failure to prior chemotherapy
  • Life expectancy of more than 3 months
  • Tissue sample desired for genomic study
  • Age ≥ 18 years
  • Performance status (WHO) < 3
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
  • Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  • Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  • Informed consent

Exclusion Criteria:

  • Have previously received pemetrexed or TKIs
  • Other concurrent uncontrolled illness

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
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Drug: Erlotinib
150 mg Given orally
Other Names:
  • Tarceva
Experimental: Pemetrexed
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Drug: Pemetrexed
500mg/m2 Given IV
Other Names:
  • ALIMTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Tumor Response
Time Frame: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.
Overall Survival
Time Frame: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.
From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.

Collaborators and Investigators

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

Sponsor

Si-Yu Wang

Investigators

  • Principal Investigator: Si-Yu Wang, Doctor, Sun Yat-sen University

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

December 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wsy001

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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