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Completed

NCT Number: NCT01287754

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung 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 4

Primary location

Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/=18 years of age
  • Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
  • Measurable disease according to RECIST criteria
  • ECOG performance status 0-2
  • Adequate haematological, renal and liver function

Exclusion criteria

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Symptomatic cerebral metastases
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Concomitant use of coumarins

Treatment and study plan

erlotinib [Tarceva]

Drug

150 mg daily orally

Primary outcomes

  1. Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation

    Time frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years

    PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.

Secondary outcomes

  1. Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1

    Time frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years

    Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.

  2. Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants

    Time frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years

    OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.

  3. Percentage of Participants Alive at 6 and 12 Months

    Time frame: At 6 and 12 months

    Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.

  4. Percentage of Participants With EGFR Mutation at Screening

    Time frame: Screening

    Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2011
Registry last updated
Jun 2, 2015

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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