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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 16, 2021

Primary Completion Date

November 15, 2026

Study Completion Date

November 15, 2027

Conditions
Lung DiseasesCarcinoma, Non-Small-Cell LungStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerRespiratory Tract NeoplasmsCarcinoma Bronchiogenic Stage IIIThoracic Neoplasms
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."

Trial Locations (22)

15006

Hospitalario Universitario A Coruña, A Coruña

17007

ICO Girona, Hospital Josep Trueta, Girona

23007

Hospital Universitario de Jaén, Jaén

27003

Hospital Universitario Lucus Augusti, Lugo

28031

Hospital Universitario Infanta Leonor, Madrid

28040

Hospital Clínico San Carlos, Madrid

Hospital Universitario Fundación Jiménez Díaz, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

28911

Hospital Universitario Severo Ochoa, Leganés

32005

Hospital Santa María Nai, Ourense

35016

Hospital Universitario Insular de Gran canaria, Las Palmas de Gran Canaria

46010

Hospital Clínico de Valencia, Valencia

46014

Hospital General Universitario de Valencia, Valencia

47003

Hospital Clínico Universitario de Valladolid, Valladolid

48013

Hospital de Basurto, Bilbao

03203

Hospital General Universitario de Elche, Elche

08916

ICO Badalona, Hospital Germans Trias i Pujol, Badalona

03010

Hospital General Universitario de Alicante, Alicante

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08208

Hospital Parc Taulí, Barcelona

07120

Hospital Son Espases, Palma de Mallorca

All Listed Sponsors
lead

Fundación GECP

OTHER