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Design
§
Phase II, single-arm, open-label multicenter study in operable and resectable
stage IIIA N2-NSCLC adult patients followed by adjuvant treatment during 1
year
§
Neoadjuvant treatment:
§
Nivolumab 360mg IV
Q3W
+ Paclitaxel 200mg/m
2
+ Carboplatin AUC 6 IV
Q3W
,
three cycles
§
After completion of neoadjuvant therapy and before surgery, a tumor
assessment will be done. Patients are allowed to leave the study if there is
evidence of progression. These patients may be considered for surgery
§
Surgery in the 3rd or 4th week from day 21 cycle 3 of neoadjuvant
treatment
§
Adjuvant treatment:
§
N
ivolumab 240mg IV Q2W for 4 months and Nivolumab 480mg IV Q4W for
8 months (1 year total) after surgical resection