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
Overview
- Phase
- Phase 2
- Intervention
- Erlotinib
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 30
- Locations
- 9
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
Erlotinib
Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
Intervention: Erlotinib
Outcomes
Primary Outcomes
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
Time Frame: 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])
Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Secondary Outcomes
- Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1(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]))
- Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population(Screening (21 days prior to Day 1))
- Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator(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]))
- Overall Survival(Baseline up to 5 years)
- Percentage of Participants With Adverse Events(Baseline up to 5 years)