A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.

Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

Population: The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis.

The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state.

Time frame: Baseline and end of study (approximately 4 years and 9 months)

Population: Participants without disease progression who filled out the FACT-L questionnaire.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Time frame: Baseline up to approximately 4 years and 9 months

Population: The safety population was identical to the ITT population, which included all participants enrolled in the study.

Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. 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 CR and 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. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

Population: The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis.

Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.

Time frame: Screening up to approximately 7 days

Population: This study had 2 phases: 1st phase - included 375 patients assessed for EGFR mutations 30 patients (out of these 375) had EGFR mutations and they were included in 2nd phase - treatment with Erlotinib.

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.

Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

Population: The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis.