Back to resultsA Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
erlotinib [Tarceva]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
- Measurable disease according to RECIST criteria
- ECOG performance status 0-2
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Previous chemotherapy or therapy against EGFR for metastatic disease
- History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
- Symptomatic cerebral metastases
- Pre-existing parenchymal lung disease such as pulmonary fibrosis
- Concomitant use of coumarins
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.
Secondary Outcome Measures
Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1
Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.
Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants
OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.
Percentage of Participants Alive at 6 and 12 Months
Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.
Percentage of Participants With EGFR Mutation at Screening
Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01287754
Brief Title
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
Official Title
A 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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150 mg daily orally
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
Description
PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.
Time Frame
Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Secondary Outcome Measure Information:
Title
Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1
Description
Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.
Time Frame
Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Title
Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants
Description
OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.
Time Frame
Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Title
Percentage of Participants Alive at 6 and 12 Months
Description
Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.
Time Frame
At 6 and 12 months
Title
Percentage of Participants With EGFR Mutation at Screening
Description
Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.
Time Frame
Screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/=18 years of age
Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
Measurable disease according to RECIST criteria
ECOG performance status 0-2
Adequate haematological, renal and liver function
Exclusion Criteria:
Previous chemotherapy or therapy against EGFR for metastatic disease
History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
Symptomatic cerebral metastases
Pre-existing parenchymal lung disease such as pulmonary fibrosis
Concomitant use of coumarins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
City
Oulu
ZIP/Postal Code
90029
Country
Finland
City
Pori
ZIP/Postal Code
28500
Country
Finland
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
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