A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287754
• Other study ID #: ML25575
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2011
• Last updated: June 1, 2015
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• erlotinib [Tarceva]
150 mg daily orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Per standard of care (every 3 months) until discontinuation for up to approximately 2 years	No
Secondary	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.	Per standard of care (every 3 months) until discontinuation for up to approximately 2 years	No
Secondary	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.	Per standard of care (every 3 months) until discontinuation for up to approximately 2 years	No
Secondary	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.	At 6 and 12 months	No
Secondary	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.	Screening	No