The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
461
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Event-Free Survival (EFS) by BICR
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
Time frame: From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.
Time frame: From randomization and the date of death due to any cause.
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
Time frame: From randomization up to approximately 44 months
Major Pathological Response (MPR) Rate
Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
Time frame: From randomization up to approximately 44 months
The Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0104
Tampa, Florida, United States
Local Institution - 0040
Atlanta, Georgia, United States
Local Institution - 0120
Augusta, Georgia, United States
Local Institution - 0145
Chicago, Illinois, United States
Local Institution - 0078
Chicago, Illinois, United States
Local Institution - 0121
Orland Park, Illinois, United States
Rcca Md Llc
Bethesda, Maryland, United States
Local Institution - 0076
Boston, Massachusetts, United States
Local Institution - 0074
Newton, Massachusetts, United States
Local Institution - 0086
Traverse City, Michigan, United States
...and 98 more locations
Time frame: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
The Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Time frame: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
The Number of Participants With Select Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
Time frame: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)