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Biomarkers Impact On the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Positive Mutation - BIOTEC


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Biomarkers Impact On the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Positive Mutation - BIOTEC


Inclusion Criteria:



- Adult patients, >=18 years of age

- Histological documented adenocarcinoma, locally advanced - stage IIIB, metastatic -
stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Life expectancy >=12 weeks

- Evidence of disease with at least one measurable disease criteria as evaluated by
Response Evaluation Criteria in Solid Tumors (RECIST)

- Adequate haematological, liver and renal function

Exclusion Criteria:

- Known hypersensitivity to erlotinib or any of its excipients

- Squamous non-small cell or small cell tumors or absence of histological report

- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment

- Prior exposure to inhibitors of Epidermal Growth Factor Receptor (EGFR)

- Prior chemotherapy or treatment with another systemic anti-cancer agent for the
treatment of the patient's current stage of disease

- Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjögrens syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions

- Radical radiotherapy with curative intent within 28 days prior to enrolment

- Any active non-controlled systemic disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of progression-free survival by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

From baseline until 40 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Romania: National Medicines Agency

Study ID:

ML22606

NCT ID:

NCT01153984

Start Date:

June 2011

Completion Date:

July 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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