A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

Number of non-HBV participants experiencing high grade (combined CTCAE v4 Grade 3-4 and Grade 5) treatment-related select adverse events in non-HBV infected participants. To evaluate safety and tolerability in non-HBV infected participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or after one prior systemic therapy and are treated with nivolumab monotherapy with an infusion duration of 30 minutes. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 100 days post dose, up to approximately 36 months

Population: All treated non-HBV infected participants

Duration of Response (DOR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who neither progress nor die will be documented on the date of their last assessment. The censoring algorithm for DOR will be the same as used for PFS definition. This endpoint will only be evaluated for participants with the best overall response of complete response or partial response.

Time frame: From the date of first confirmed response to the date of the first documented tumor progression, up to approximately 30 months

Population: This is a single arm trial with two enrollment cohorts, HPV positive and HPV negative. All participants received the same treatment. Due to the small number of participants in the HPV cohorts, it is not meaningful to perform additional subgroup analysis. For example, there were only 17 participants in the HPV positive cohort, which is less than 5% (17/400 = 4.25%) from the overall. Therefore, all additional efficacy subgroup analysis was performed based on all treated participants.

Number of HBV participants experiencing high grade (combined CTCAE v4 Grade 3-4 and Grade 5) treatment-related select adverse events in HBV participants. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 100 days post dose, up to approximately 36 months

Population: All treated HBV infected participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 100 days post dose, up to approximately 36 months

Population: All treated participants

Number of Participants experiencing laboratory abnormalities are defined as on-study lab parameters summarized by using the worst grade per NCI CTCAE v.4 criteria

Time frame: From first dose up to 100 days post last dose, up to approximately 36 months

Population: All treated participants

Number of participants experiencing laboratory abnormalities are defined as on-study lab parameters summarized by using the worst grade per NCI CTCAE v.4 criteria

Time frame: From randomization to 100 days post last dose, up to 36 months

Population: All treated participants

Number of Participants experiencing SAEs are tabulated using worst grade per NCI CTCAE v.4 criteria by system organ class and MedDRA preferred term.

Time frame: From first dose to 100 days post last dose, up to 36 months

Population: All treated participants

Objective Response Rate (ORR) is defined as the percentage of all treated subjects whose best overall response (BOR) from baseline is either a CR or PR per RECIST 1.1 criteria. BOR is determined by the best response designation recorded between the first dose date and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For subjects without documented progression or subsequent anticancer therapy, all available response designations will contribute to the BOR determination. For subjects who continue nivolumab beyond progression, the BOR should be determined based on response designations recorded at the time of the initial RECIST 1.1 defined progression.

Time frame: From the first dose date up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. Up to approximately 36 months

Population: This is a single arm trial with two enrollment cohorts, HPV positive and HPV negative. All participants received the same treatment. Due to the small number of participants in the HPV cohorts, it is not meaningful to perform additional subgroup analysis. For example, there were only 17 participants in the HPV positive cohort, which is less than 5% (17/400 = 4.25%) from the overall. Therefore, all additional efficacy subgroup analysis was performed based on all treated participants.

Overall survival (OS) is defined as the time from the first dosing date to the date of death. Participants without documentation of death will be recorded on the last date the participant was known to be alive. Tumor PD-L1 protein expression was measured by immunohistochemistry (IHC).

Time frame: From the first dose up to the date of death. Participants without documentation of death will be censored on the late date known to be alive, up to approximately 32 months

Population: This is a single arm trial with two enrollment cohorts, HPV positive and HPV negative. All participants received the same treatment. Due to the small number of participants in the HPV cohorts, it is not meaningful to perform additional subgroup analysis. For example, there were only 17 participants in the HPV positive cohort, which is less than 5% (17/400 = 4.25%) from the overall. Therefore, all additional efficacy subgroup analysis was performed based on all treated participants.

PFS is the time from first dose to the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who die without a reported prior progression are considered to have progressed on their death date. Participants who did not progress or die will be documented on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be documented on their first dose date. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be documented at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Tumor PD-L1 protein expression was measured by immunohistochemistry (IHC). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame: From the first dose up to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, up to approximately 30 months

Population: This is a single arm trial with two enrollment cohorts, HPV positive and HPV negative. All participants received the same treatment. Due to the small number of participants in the HPV cohorts, it is not meaningful to perform additional subgroup analysis. For example, there were only 17 participants in the HPV positive cohort, which is less than 5% (17/400 = 4.25%) from the overall. Therefore, all additional efficacy subgroup analysis was performed based on all treated participants.

Time to Treatment Failure is defined as the minimum of the time from treatment assignment to disease progression (determined by investigator assessments using RECIST 1.1), death or last dose date if a participant progressed, died or discontinued from treatment for any reasons other than maximum clinical benefit and administrative reasons by sponsor. TTF is censored at the last dose date for participants who continued on treatment without progression (per RECIST 1.1) or death at the time of the database lock. Tumor PD-L1 protein expression was measured by immunohistochemistry (IHC).

Time frame: From treatment assignment to disease progression, death or last dose date, up to approximately 16 months

Population: This is a single arm trial with two enrollment cohorts, HPV positive and HPV negative. All participants received the same treatment. Due to the small number of participants in the HPV cohorts, it is not meaningful to perform additional subgroup analysis. For example, there were only 17 participants in the HPV positive cohort, which is less than 5% (17/400 = 4.25%) from the overall. Therefore, all additional efficacy subgroup analysis was performed based on all treated participants.