Spots Global Cancer Trial Database for NADIM II: Neo-Adjuvant Immunotherapy
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Trial Identification
Brief Title: NADIM II: Neo-Adjuvant Immunotherapy
Official Title: A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.
Study ID: NCT03838159
Conditions
Study Description
Brief Summary: This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. 90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.
Detailed Description: This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W. Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days followed by surgery. The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone. Patient accrual is expected to be completed within 3 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 8.5 years. Patients will be followed 5 years after adjuvant treatment or surgery. The study will end once survival follow-up has concluded.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ICO Badalona, Badalona, Barcelona, Spain
ICO Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Insular de Gran canaria, Las Palmas De Gran Canaria, Gran Canaria, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Complejo Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain
Hospital Universitario de Cruces, Baracaldo, Vizcaya, Spain
Hospital General de Alicante, Alicante, , Spain
Hospital Universitari Dexeus, Barcelona, , Spain
Hospital Universitari Vall d' Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital de Sant Pau, Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital Dr. Josep Trueta, Girona, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital General Universitario de Málaga, Málaga, , Spain
Hospital Clínico de Salamanca, Salamanca, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital General de Valencia, Valencia, , Spain
Hospital Clínico Universitario de Valladolid, Valladolid, , Spain
Hospital Clínico Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: Mariano Provencio, MD
Affiliation: Hospital Puerta del Hierro
Role: PRINCIPAL_INVESTIGATOR
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