Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.
Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months. Three cycles of neoadjuvant chemotherapy in combination with nivolumab will be administered. After completion of neoadjuvant therapy (3 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression. Patients with in-stable disease or partial response may be considered for surgery. The report imaging response vs pathological response rate will be evaluated. Patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. The total number of patients to be included will be 46 from 23 participating sites in Spain. Accrual period of 1.5 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 46 patients. After that all patients will be treated for 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6 IV Q3W
Complejo hospitalario de la coruña
A Coruña, Coruña, Spain
Progression Free Survival
The progression free survival is the percentage of the patients without disease progression
Time frame: at 24 months from the first dose of neoadjuvant treatment
Overall Survival
Percentage of patients are still alive
Time frame: at 3 years from the first dose of neoadjuvant treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Reina Sofía
Córdoba, Córdoba, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario de Vigo
Vigo, Pontevedra, Spain
Hospital de Cruces
Bilbao, Vizcaya, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Universitari Quirón Dexeus
Barcelona, Spain
Hospital Universitari Vall Hebrón
Barcelona, Spain
...and 14 more locations