A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer

OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.

Time frame: Randomization to date of death from any cause up to 35.8 months post-randomization

Population: Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39.

DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions

Time frame: Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization

Population: Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0.

PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.

Time frame: Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization

Population: Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10.

Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.

Time frame: Randomization to date of death from any cause up to 35.8 months post-randomization

Population: Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle.

TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.

Time frame: Randomization to first date of PD up to 23.7 months post-randomization

Population: Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19.

TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.

Time frame: Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization

Population: Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91.

Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.

Time frame: Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization

Population: Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy.

DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.

Time frame: Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization

Population: Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy.

SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.

Time frame: Randomization to date of toxicity or date of death up to 34.6 months post-randomization

Population: Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10.