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Resection rate is defined as the proportion of all participants who underwent definitive surgery. Participants who undergo (ie, start) surgery with the goal of complete tumour resection will be counted as meeting this endpoint.
pCR will be defined as the proportion of participants who undergo surgery and have 0% residual viable tumour cells in resected lung and lymph nodes.
OS will be defined as the time from first dose of study intervention until the date of death due to any cause.
The proportion of participants alive at 12 and 24 months.
EFS is defined as the time from the first dose of study intervention to any of the following events: PD that precludes surgery, progression or recurrence of disease after surgery, PD in the absence of surgery, disease progression, recurrence, or death due to any cause.
The proportion of participants alive and event-free at 12 and 24 months.
The proportion of participants alive without disease progression at 12 and 24 months.
Circulating tumour DNA clearance (ie, cMR) will be defined as a change from detectable ctDNA to undetectable ctDNA (ctDNA concentration less than limit of detection) at specified timepoints. The percentage of all biomarker-evaluable participants with ctDNA clearance will be assessed.
Safety and tolerability will be evaluated in terms of adverse events and serious adverse events.
Intended surgical approach at baseline (minimally invasive vs open thoracotomy).
Actual surgical approach (minimally invasive vs open thoracotomy).
Intended surgical procedure (lobectomy vs bilobectomy vs sleeve resection vs pneumonectomy).
Actual surgical procedure (lobectomy vs bilobectomy vs sleeve resection vs pneumonectomy)
Resection rate will be further assessed separately in participants deemed resectable at baseline and participants deemed borderline resectable at baseline.
The R0, R1, and R2 resection rates (assessed separately) are defined as the proportion of resected participants with resection margins assessed as R0, R1, and R2 respectively. R0 corresponds to resection for cure or complete remission, R1 to microscopic residual tumour, R2 to macroscopic residual tumour.
PFS is defined as the time from the first dose of study intervention to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.-defined PD, as assessed by the investigator, or death due to any cause.
ORR is defined as the proportion of participants who have unconfirmed complete response or partial response as assessed by the investigator per RECIST 1.1.
ORR is defined as the proportion of participants who have unconfirmed complete response or partial response as assessed by the investigator per RECIST 1.1.
The safety of study intervention will be evaluated from start to end of surgery
The safety of study intervention will be evaluated during post operative hospital stay
The safety of study intervention will be evaluated for participants with delayed surgery
The safety of study intervention will be evaluated during the length of the surgical delay
The safety of study intervention will be evaluated for participants with reason of surgical delay
The safety of the study intervention will be evaluated from last neoadjuvant dose to surgery