OS was defined as the time between the date of randomization and the date of death due to any cause. Kaplan-Meier (KM) estimates were used to calculate median.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.

OS was defined as the time between the date of randomization and the date of death due to any cause. OS rate at 6, 12, 18 and 24 months were estimated for each treatment arm using Kaplan Meier methodology. Percentages were rounded off to the nearest decimal point.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.

Objective response rate (ORR)=best overall response (BOR) of either complete response (CR)/partial response (PR), as determined by investigator with use of RECIST v1.1. CR= disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A minimum interval of 6 weeks (42 days) was considered for stable disease (SD) to be assigned as BOR, i.e. in case the single response is SD, PR or CR, this single response must have been assessed no less than 6 weeks (at least 42 days) after start date of study treatment. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the diameters while in the study. Percentages were rounded off to the nearest decimal point.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.

PFS was defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first. Progressive disease (PD) was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. KM estimates were used to calculate median.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.

DOR was defined as the time from the first tumor assessment that supports the participants' objective response (CR or PR, whichever is first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first, among participants who have a best overall response as CR or PR. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. KM estimates were used to calculate median.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received. Overall number analyzed is the number of participants with objective response (i.e. responders).

An AE was any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).

Safety-evaluable population included all randomized participants who received any amount of study treatment.

EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of patient functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). It was scored according to EORTC scoring manual (Fayers et al. 2001). All EORTC scales & single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high/healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score was perceived by participants as clinically significant (Osoba et al. 1998). A positive change from baseline=improvement & negative change from baseline indicated worsening.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 was scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score was perceived by participants as clinically significant (Osoba et al. 1998). A positive change from baseline indicates improvement and negative change from baseline indicated worsening.

ITT Population included all randomized participants irrespective of whether the assigned treatment was actually received. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

TTD with use of the EORTC was defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms was defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score was perceived by participants as clinically significant (Osoba et al. 1998).

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.

TTD with use of the EORTC was defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms was defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score was perceived by participants as clinically significant.

ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.

OS was defined as the time between the date of randomization and the date of death due to any cause. OS was assessed in participants whose tumors express PD-L1 protein (i.e., tumor cell (TC) ≥1%) as measured by PD-L1 SP263 immunohistochemistry (IHC) assay. KM estimates were used to calculate the median.

ITT Population included all randomized participants irrespective of whether the assigned treatment was actually received. Overall number analyzed is the number of participants with data available for analysis.

PFS was defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. Investigator-assessed PFS was assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. KM estimates were used to calculate the median.

ITT Population included all randomized participants irrespective of whether the assigned treatment was actually received. Overall number analyzed is the number of participants with data available for analysis.