Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

erlotinib [Tarceva]

Clinical Trials

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.

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

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

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.

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.

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.

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.

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.

Hoffmann-La Roche

Only participants treated with erlotinib were assessed for adverse events.

Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.

Erlotinib

Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.

Untreated

Total

Age, Continuous

Sex: Female, Male

All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated patients, were included in the analysis.

Medical Communications

All Participants Treated: All participants who received at least one dose of erlotinib were included in the analysis.

Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation

Partial response

Unmeasurable

Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1

Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.

All Participants Enrolled: All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated participants, were included in the analysis.

Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants

At 6 months

At 12 months

Percentage of Participants Alive at 6 and 12 Months

All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (n = 3) received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.

All Participants

Percentage of Participants With EGFR Mutation at Screening

Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial