A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Time frame: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

Population: All randomized participants

Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

Population: Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.

The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).

Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

Population: Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.

To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Time frame: Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)

Population: Randomized participants with reviewable scan--(316/359 \[88%\] Maintenance arm and 156/180 \[87%\] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).

OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.

Time frame: Date of randomization to the date of death from any cause up to 39.5 months

Population: All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.

A summary of non-serious AEs is located in the Reported Adverse Event Module.

Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)

Population: Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.

Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

Population: All randomized participants

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm\*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm\*100.

Time frame: Date of randomization to date of measured PD (up to 19.3 months)

Population: All randomized participants

Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.

Time frame: Baseline to date of measured progressive disease (up to 19.3 months)

Population: All randomized participants

A summary of serious adverse events is located in the Reported Adverse Event Module.

Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)

Population: Randomized population with all serious adverse events included.