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


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

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Trial Information

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


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung
cancer with mutations in the tyrosine kinase domain of the epidermal growth factor
receptor (EGFR)

- At least one measurable lesion according to RECIST criteria

- European Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate hematological, liver and renal function

- Patients with stable cerebral metastases who have received surgical or radiotherapy
will be eligible

Exclusion Criteria:

- Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or
adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before
entering the study)

- History of another neoplasm except for carcinoma in situ of the cervix, adequately
treated basal cell skin carcinoma, radically treated prostate carcinoma with good
prognosis (Gleason disease in the last 5 years

- Symptomatic cerebral metastases

- Any significant ophthalmologic abnormality

- Use of coumarins

- Pregnant or breast-feeding women

- Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and
carcinomatosis (if this is the only presence of the 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:

Progression-free survival (tumour assessments according to RECIST criteria)

Outcome Time Frame:

up to 6 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

to: be added

Study ID:

ML25423

NCT ID:

NCT01372384

Start Date:

January 2012

Completion Date:

November 2014

Related Keywords:

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

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