75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment

Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.

Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".

Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.

Total of all reporting groups

Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIA - the cancer has spread to nearby tissue or spread to far away lymph nodes; Stage IIIB - cancer spread to opposite side of chest, more than one tumor within same lobe of lung; Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.

Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.

Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.

Intent to treat population. Patient censored:

pemetrexed=25, docetaxel=39.

Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".

Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.

Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.

Patients who received at least one dose of study drug.

Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.

Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.

Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.

Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.

75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.

Resulted in death in one pemetrexed patient.

Resulted in death in one docetaxel patient.

Resulted in death in one docetaxel patient.

Resulted in death in one docetaxel patient.