The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
505
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
Time frame: From randomization up to a median of 30 months after randomization.
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Time frame: From randomization up to a median of 30 months after randomization.
Overall Survival (OS)
Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
Time frame: From randomization to the date of death (Up to approximately 93 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
This arm is closed and no longer enrolling patients.
Local Institution - 0121
Glendale, Arizona, United States
Local Institution - 0081
Los Angeles, California, United States
Local Institution - 0025
Denver, Colorado, United States
Local Institution - 0007
Plainville, Connecticut, United States
Local Institution - 0173
Hollywood, Florida, United States
Local Institution - 0136
Miami, Florida, United States
Local Institution - 0054
Orlando, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Indian River Medical Center
Vero Beach, Florida, United States
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, United States
...and 128 more locations
Time to Death or Distant Metastases (TTDM)
TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.
Time frame: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)