A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Overall survival (OS)

Timeframe: Up to approximately 6 years

OS is defined as the time from randomization until the date of death due to any cause.

Progression-free survival (PFS)

Timeframe: Up to approximately 6 years

PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).

Landmark overall survival (OS) rates

Timeframe: Up to approximately 6 years

OS is defined as the time from randomization until the date of death due to any cause.

Landmark progression-free survival (PFS) rates

Timeframe: Up to approximately 6 years

PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).

Time to second progression or death (PFS2)

Timeframe: Up to approximately 6 years

PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice.

Overall response rate (ORR)

Timeframe: Up to approximately 6 years

ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

Duration of response (DoR)

Timeframe: Up to approximately 6 years

DoR is defined as the time from the date of first documented response until the date of documented progression using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).

Pharmacokinetic (PK) of rilvegostomig

Timeframe: Up to approximately 6 years

Concentration of rilvegostomig in serum.

Immunogenicity of rilvegostomig

Timeframe: Up to approximately 6 years

Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.

Patient-reported physical functioning

Timeframe: Up to approximately 6 years

Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.

Patient-reported global health status (GHS)/quality of life (QoL)

Timeframe: Up to approximately 6 years

Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.

Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)

Timeframe: Up to approximately 6 years

Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration.