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Completed

NCT Number: NCT00294762

Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Heartlands Hospital, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18
  • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
  • Radiologically measurable or evaluable disease No prior chemotherapy
  • 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
  • Tumor tissue block or fine needle aspirate

Exclusion criteria

  • Any concurrent anticancer therapy or radiation
  • Other active malignancy
  • Uncontrolled brain metastases
  • GI abnormalities
  • Severe abnormalities of the cornea
  • Significant cardiac disease
  • Active infection

Treatment and study plan

Tarceva

Drug

oral tablet

Other names: erlotinib, OSI-774

carboplatin

Drug

IV

paclitaxel

Drug

IV

Primary outcomes

  1. 6-month Progression-free Survival

    Time frame: 6 months after first dose

    Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Secondary outcomes

  1. Progression-free Survival

    Time frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)

    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

  2. Overall Survival at 12 Months

    Time frame: 12 months from 1st dose

    Percentage of patients alive after 12 months of study treatment

  3. Overall Survival

    Time frame: From first study treatment until time of death (maximum 29.0 months)

    Median number of months from first study treatment until time of death

  4. Best Tumor Response

    Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)

    Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline

  5. Duration of Tumor Response

    Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).

    Median length of time that tumor showed any type of response, ie, CR, PR, or SD

Sponsors and collaborators

Lead sponsor

OSI Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2006
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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