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Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
Sponsor: Fundación GECP
Summary
This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled. The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not. Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.
Official title: Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
97
Start Date
2025-07-08
Completion Date
2035-05-02
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
Atezolizumab
Patients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
Paclitaxel
Neoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Paclitaxel: Intravenous infusion. Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Carboplatin
Neoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin\* \*Infusion according to the standard of each center Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
Locations (21)
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Parc Taulí
Barcelona, Barcelona, Spain
Hospital De Basurto
Bilbao, Bilbao, Spain
Hospital Univ. De Jerez De La Frontera
Jerez de la Frontera, Cadiz, Spain
ICO Girona, Hospital Josep Trueta
Girona, Girona, Spain
Hospital Universitario Clinico San Cecilio
Granada, Granada, Spain
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitari de Gran Canària Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain
Complejo Hospitalario de Navarra
Pamplona, Pamplona, Spain
Hospital Universitario Salamanca
Salamanca, Salamanca, Spain
Hospital Universitario Nuestra Señora La Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Del Rocio
Seville, Sevilla, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain