Avelumab in First-line NSCLC (JAVELIN Lung 100)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Time frame: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+HRQoL analysis set includes all high expression PD-L1 FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Time frame: Baseline, End of treatment (Week 283.9)

Population: High PD-L1+modified HRQoL analysis set includes all high expression PD-l1+ mFAS participants who have 1 baseline HRQoL assessment and have ≥1 post-baseline HRQoL questionnaire completed. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

Time frame: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+ HRQoL analysis set includes all high expression PD-L1+ FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

Time frame: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+ modified HRQoL analysis set was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable for specified categories.

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Time frame: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+HRQoL analysis set includes all high expression PD-L1+ FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Time frame: Baseline, End of treatment (Week 283.9)

Population: High PD-L1+ Modified HRQoL Analysis Set included all mFAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire completed. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ FAS was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ mFAS was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value (that is \[i.e.\] highest score).

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with changes from baseline in increased Body Temperature (degree Celsius \[°C\]) were reported by using criteria: Baseline temperature (temp.) less than (\<) 37°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, greater than or equal to (\>=)3°C and missing; Baseline temp. 37 - \<38°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 38 - \<39°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 39-\<40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. \>=40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. missing, on treatment change missing.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) heart rate (HR) (beats per minute \[bpm\]) were reported by using criteria: Ic./Dc. BS HR \<100/\>=100 bpm, on treatment change =\<20 bpm, \>20 - =\<40 bpm, \>40 bpm and missing; Ic./Dc. BS HR missing, on treatment change missing.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR \<20 breaths per minute (breaths/min), on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing. Ic./Dc. BS RR missing, on TR change missing. Ic./Dc. BS RR \>=20 breaths/min, on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing.

Time frame: Time from date of randomization up to data cutoff (assessed up to 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) (millimeter of mercury \[mmHg\]) were reported by using criteria: Ic./Dc. BS SBP \<140 mmHg and \>=140 mmHg, on maximal treatment (TR) change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS SBP missing, on maximal treatment (TR) change missing; Ic./Dc. BS DBP \<90 mmHg and \>= 90 mmHg, on maximal TR change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS DBP missing on maximal TR change missing.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment changes from baseline in Increase (Ic.)/Decrease (Dc.) in maximal weight were reported by using criteria: Ic./Dc. From baseline, on treatment (TR) change \<10 percentage (%), \>=10% and missing.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

ECG parameters included heart rate, PR interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). PCSA criteria for abnormal value of ECG parameters: any heart rate \<= 50 bpm and decrease from baseline \>=20 bpm , any hear rate \>= 120 bpm and increase from baseline \>= 20 bpm; PR interval: \>= 220 milliseconds (ms) and increase from baseline \>= 20 ms; QRS interval \>= 120 ms; QTcF \> 450 ms, \> 480 ms, \> 500 ms, QTcF increase from baseline \> 30 ms and QTcF increase from baseline \> 60 ms; QTcB \> 450 ms, \> 480 ms, \> 500 ms, QTcB increase from baseline \> 30 ms and QTcB increase from baseline \> 60 ms.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Number of participants with shifts from Baseline values (Grade 0/1/2/3) to abnormal post-baseline values (shift to \>= Grade 4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in laboratory parameter (anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased and Hyperglycemia) were reported.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAEs were those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period TEAEs included both serious TEAEs and non-serious TEAEs. Any AE that was suspicious to be a potential Immune-related adverse event (irAE) including infusion related reactions were considered AESIs. Number of participants with TEAEs and AESIs were reported.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: FAS included all participants who were randomized to study intervention.

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: mFAS included all participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation.

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ FAS included all high expression PDL-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Time frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).