A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.

Time frame: Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)

Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD.

OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.

Time frame: Enrollment to the date of death from any cause (up to 30.8 months)

Population: Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off.

OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.

Time frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)

Population: Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively.

Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria.

Time frame: Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)

Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.

Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria.

Time frame: Enrollment to date of progressive disease (up to 18 months)

Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.

Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria.

Time frame: Enrollment to date of progressive disease (up to 18 months)

Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.

Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments.

Time frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)

Population: Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.

Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria.

Time frame: Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)

Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.

Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.

Time frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)

Population: Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off.