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ACTIVE NOT RECRUITING
NCT04776447
PHASE2

Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO)

Sponsor: Fundación GECP

View on ClinicalTrials.gov

Summary

Open-label, non-randomized, phase II multi-centre controlled clinical trial. 51 non-resectable stage IIIA-IIIB non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival at 12 months

Official title: A Phase II Trial of Atezolizumab Plus Induction Chemotherapy (CT) Plus Chemo-radiotherapy and Atezolizumab Maintenance Therapy in Non-resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2021-06-16

Completion Date

2027-11-15

Last Updated

2025-04-09

Healthy Volunteers

No

Interventions

DRUG

Carboplatin

Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02

DRUG

Placlitaxel

Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. 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

Atezolizumab

Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Atezolizumab targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells. Patients will receive 1200 mg of atezolizumab administered by IV infusion every 21 days (+/- 3 days) in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.

Locations (22)

Hospital General Universitario de Elche

Elche, Alicante, Spain

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Parc Taulí

Barcelona, Spain

Hospital de Basurto

Bilbao, Spain

ICO Girona, Hospital Josep Trueta

Girona, Spain

Hospital Universitario de Jaén

Jaén, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Santa María Nai

Ourense, Spain

Hospital Son Espases

Palma de Mallorca, Spain

Hospital Clínico de Valencia

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain