A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)

IRF-assessed pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

IRF-assessed pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

IRF-assessed MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

IRF-assessed MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator (confirmation not required) according to RECIST v1.1 during the neo-adjuvant treatment phase. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.

ORR was defined as the percentage of participants with a best overall response of CR or PR, as assessed by the investigator (confirmation not required) according to RECIST v1.1 during the neo-adjuvant treatment phase. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.

OS was defined as the time from randomization to death from any cause during the course of the study. K-M method was used to estimate the median OS.

OS was defined as the time from randomization to death from any cause during the course of the study. K-M method was used to estimate the median OS.

EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median Investigator-assessed EFS.

EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median Investigator-assessed EFS.

DFS was defined as the time from the first date of no disease (i.e., date of surgery) to local or distant recurrence (including occurrence of new primary NSCLC), or death due to any cause, whichever occurred first, as determined by the investigator during the adjuvant treatment and observation follow-up. DFS was analyzed only for participants who underwent surgery and had no evidence of residual NSCLC disease. K-M method was used to estimate median investigator-assessed DFS.

DFS was defined as the time from the first date of no disease (i.e., date of surgery) to local or distant recurrence (including occurrence of new primary NSCLC), or death due to any cause, whichever occurred first, as determined by the investigator during the adjuvant treatment and observation follow-up. DFS was analyzed only for participants who underwent surgery and had no evidence of residual NSCLC disease. K-M method was used to estimate median investigator-assessed DFS.

2-year and 3-year OS rates were defined as the percentage of participants who were alive 2 years and 3 years after randomization. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the OS rate. Percentages have been rounded off.

2-year and 3-year OS rates were defined as the percentage of participants who were alive 2 years and 3 years after randomization. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the OS rate. Percentages have been rounded off.

2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. IRF-assessed EFS was defined as the time from randomization to the first occurrence of PD per RECIST v1.1 that precluded surgery, local or distant disease recurrence (including occurrence of new primary NSCLC), or death from any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.

2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. IRF-assessed EFS was defined as the time from randomization to the first occurrence of PD per RECIST v1.1 that precluded surgery, local or distant disease recurrence (including occurrence of new primary NSCLC), or death from any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.

2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.

2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Participants were asked to answer the following questions for GHS/QoL: "How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?" These questions were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0-100. High score on GHS/QoL scale indicates better HRQoL.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Participants were asked to answer the following questions: "How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?" These questions were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score on GHS/QoL scale indicates better HRQoL.

AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any AE that met any of the following criteria: was fatal; was life-threatening; required or prolonged in-patient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a significant medical event in the investigator's judgment.

AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants with immune-mediated AEs have been reported here.

Participants were scheduled to undergo surgical resection of their tumor upon completion of 4 cycles of neo-adjuvant therapy. Prior to the surgery, the attending surgeon and medical oncologist assessed the participant to check if it was clinically feasible for them to undergo surgery (pre-surgery visit). Pre-surgery visit occurred within 30 days after the last dose of neo-adjuvant treatment, and surgery was performed within 30 days after the pre-surgery visit. Assessment of surgical delays were made by assessing the data entered in the electronic case report forms (eCRFs).

Participants who underwent surgical resection of their tumor and had intraoperative or post-operative complications were reported.

Participants who did not undergo surgical resection for various reasons have been reported here.

Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response).