Clinical trial NCT01260181: A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Official title: Phase II, Open-Label 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
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: 2010-12-15
Enrollment: 30
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 single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic NSCLC with EGFR mutations
* Measurable disease according to RECIST criteria
* Adequate hematological, renal and liver function

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
timeFrame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])
Secondary outcomes:
measure: Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1
timeFrame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])
measure: Overall Survival
timeFrame: Baseline up to 5 years
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to 5 years
measure: Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population
timeFrame: Screening (21 days prior to Day 1)
measure: Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator
timeFrame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Hospital Infante D. Pedro; Servico de Oncologia Medica
city: Coimbra
country: Portugal
facility: Hospital Geral; Servico de Pneumologia
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Pneumologia
city: Lisboa
country: Portugal
facility: Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Pneumologia
city: Lisboa
country: Portugal
facility: Hospital Pulido Valente; Servico de Pneumologia
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Pneumologia
city: Vila Nova De Gaia
country: Portugal
facility: CHVNG/E_Unidade 1; Servico de Pneumologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: