OS is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. OS was a pre-specified primary endpoint for Arms A and B only.

The Intent-To-Treat (ITT) Analysis Set includes all participants who were randomized to a treatment arm.

The severity of AEs was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being the least severe and Grade 5 being the most severe.

An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, was considered a significant medical AE by the investigator based on medical judgement.

All treated participants in the Safety Run-In Substudy.

The Pharmacokinetic Analysis Set consisted of all participants who received treatment. Values are based on samples collected at each timepoint.

PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. PFS was a pre-specified secondary endpoint for Arms A and B only.

Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions.

The Intent-To-Treat Analysis Set includes all participants who were randomized to a treatment arm.

PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method.

The Analysis Set includes all participants treated in the Safety Run-In Substudy.

ORR is defined as the percentage of participants with a documented, confirmed complete response or partial response per RECIST v1.1. ORR was a pre-specified secondary endpoint for Arms A and B only.

Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions.

Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.

The Intent-To-Treat Analysis Set includes all participants who were randomized to a treatment arm.

ORR is defined as the percentage of participants with a documented, confirmed complete response or partial response per RECIST v1.1.

The Analysis Set includes all treated participants in the Safety Run-In Substudy.

DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method. DOR was a pre-specified secondary endpoint for Arms A and B only.

All participants in the Intent-To-Treat Analysis Set with a complete response or partial response.

DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method.

Participants in the Safety Run-In Substudy who were treated and had a complete response or partial response.

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 GHS scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health QoL questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life. Included in this outcome measure were evaluation of GHS/QoL, physical functioning, and fatigue.

This was a pre-specified secondary endpoint for Arms A and B only.

Results are presented for participants in the Intent-to Treat Analysis Set who had available data at each time point.

The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. The symptom index scale was calculated by taking the mean of all symptom scale scores, and ranges from 0 to 100. Lower scores indicate an improvement in symptoms.

This was a pre-specified secondary endpoint for Arms A and B only.

Results are presented for participants in the ITT Analysis Set with available data at each time point.

The EQ-5D-5L comprises a descriptive module that includes five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a Visual Analog Scale (VAS). The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes.

This was a pre-specified secondary endpoint for Arms A and B only.

Results are presented for participants in the ITT Analysis Set with available data at each time point.

TTD is defined as the time from randomization to the first occurrence of worsening scores of ≥ 10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause. TTD was estimated using the Kaplan-Meier method. TTD was a pre-specified secondary endpoint for Arms A and B only.

The ITT analysis set consists of all the participants who were randomized to a treatment arm.

TTD is defined as the time from randomization to the first occurrence of worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause. TTD was estimated using the Kaplan-Meier method. TTD was a pre-specified secondary endpoint for Arms A and B only.

The ITT analysis set consists of all the participants who were randomized to a treatment arm.

The severity of AEs was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being the least severe and Grade 5 being the most severe.

An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. An SAE is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, was considered a significant medical AE by the investigator based on medical judgement.

This was a pre-specified secondary endpoint for Arm A only.

The Safety Analysis Set includes all randomized participants who received ≥ 1 dose of study drug.

Participants in the Safety Run-In Substudy who received any dose of the study drug and for whom both baseline antidrug antibodies (ADA) and at least 1 postbaseline ADA result are available.