A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.

Time frame: Randomization to measured PD up to 38 months

Population: Qualified Intent to Treat (Q-ITT) Population defined as all participants with nonsquamous histology, who were randomized to therapy.

A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.

Time frame: Randomization up to 39 months

Population: Safety Population defined as non-squamous participants who received at least 1 dose of study therapy (pemetrexed plus erlotinib or pemetrexed or erlotinib). One participant was assigned to pemetrexed (single therapy) but received erlotinib (single therapy) at first cycle and this lead to the discrepancy of participants for the safety analysis.

EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.

Time frame: Randomization to date of PD or death up to 38 months

Population: A subset of the Q-ITT Population who had EGFR samples; Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.

OS is defined as the time from randomization to the date of death from any cause.

Time frame: Baseline to date of death from any cause up to 45.5 months

Population: Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy. Survival time was censored at the date of last contact for participants who were still alive or lost to follow-up, number of participants censored 35 (pemetrexed plus erlotinib), 44 (erlotinib) and 31 (pemetrexed).

TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.

Time frame: Randomization to measured disease progression up to 38 months

Population: Q-ITT Population - Tumor Analyzable (Q-ITT-TA) Population: defined as all participants with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.

DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.

Time frame: Randomization to disease progression up to 38 months

Population: Q-ITT-TA Population: defined as all participants, with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.

OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.

Time frame: Month 12

Population: Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.

TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).

Time frame: Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months

Population: A subset of the Q-ITT Population that included participants with LCSS results; Q-ITT Population: defined as all participants, with nonsquamous histology, who were randomized to therapy.