Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy

PFS was defined as the time from date of randomization to the first observation of progressive disease (PD) or death due to any cause. For participants 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 the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to objective disease progression or death, PFS was censored at the date of the last objective progression-free assessment prior to the initiation of post-discontinuation anticancer therapy.

Time frame: Randomization to measured PD or death from any cause up to 12.2 months

Population: All randomized participants identified by assigned treatment group. Number of participants censored: Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin = 5; Pemetrexed + Carboplatin + Bevacizumab + Placebo = 2.

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions and PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs. For participants who died without progressive disease or who were alive, DoR was censored at the last contact of progression free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to PD, DoR was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation anticancer therapy. Due to early study closure, DoR was not analyzed.

Time frame: Time of response to disease progression or death from any cause up to 12.2 months

Population: All randomized participants. Participants censored: Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin = 16; Pemetrexed + Carboplatin + Bevacizumab + Placebo = 14.

OS was defined as the time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data cutoff, OS was censored at the last contact date.

Time frame: Randomization to date of death up to 14.3 months

Population: All randomized participants identified by assigned treatment group. Participants censored: Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin = 12; Pemetrexed + Carboplatin + Bevacizumab + Placebo = 9.

Tumor response rate was defined as number of participants with overall best response of CR or PR over number of protocol qualified participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case, no new lesions may have appeared. Percentage of participants was calculated as: (number of participants with CR or PR/ number of participants qualified for tumor response analysis) × 100.

Time frame: Randomization to measured progressive disease or death from any cause up to 12.2 months

Population: All randomized participants identified by assigned treatment group.

Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs. Participants who died due to progressive disease (PD) or an AE while on treatment and or died during the 30 day post-treatment follow-up are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Time frame: Randomization up to 14.3 months and 30-day follow-up

Population: All randomized participants who received at least 1 dose of study drug.

TTPD was defined as the time from the date of randomization until the first date of objectively determined progressive disease (PD). For participants who died without objective PD (including death from study disease), TTPD was censored at the date of the last objective progression-free disease assessment. For participants not known to have died as of the data cutoff and did not have PD, TTPD was censored at the date of the last objective progression-free disease assessment.

Time frame: Randomization to measured PD or death from any cause up to 12.2 months

Population: All randomized participants.