The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min
Jessa Hospital Hasselt
Hasselt, Belgium
University Hospital Essen
Essen, Germany
Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg
Heidelberg, Germany
Netherlands Cancer Institute
Amsterdam, Netherlands
Feasibility of four weeks of preoperative immunotherapy with Nivolumab, Nivolumab plus Relatlimab (80 mg), and Nivolumab plus Relatlimab (240 mg)
Time frame: Within 43 days after first study medication
Estimation of pathological tumor response rate
Time frame: Within 43 days after first study medication (day of surgery)
Estimation of curative (R0) resection rate
Time frame: Within 43 days after first study medication (day of surgery)
Objective radiological response rate
Objective radiological response rate per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Time frame: After 3, 6, 9 and 12 months post-surgery
Disease-free survival rate at 12 months
Assessment of disease-free survival rate at 12 months per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Time frame: 12 months
Overall survival rate at 12 months
Time frame: 12 months
Morbidity
Estimation of morbidity within 90 days after surgery
Time frame: within 90 days after surgery
Mortality
Estimation of mortality within 90 days after surgery
Time frame: within 90 days after surgery
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