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RECRUITING
NCT07153445
PHASE2

Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)

Sponsor: Fundación GECP

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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