Clinical trial NCT01372384: A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility criteria: 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 \</= 6), or another curatively treated neoplasm without evidence of 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)

Primary outcomes:
measure: Progression-free Survival (Tumour Assessments According to RECIST Criteria)
timeFrame: Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.
Secondary outcomes:
measure: Objective Response Rate (Investigator Assessed)
timeFrame: Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)
measure: Safety: Incidence of Adverse Events
timeFrame: Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.
measure: Overall Survival
timeFrame: Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: