Neoplasms

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Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lung Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Carcinoma, Bronchogenic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Diseases

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

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Paclitaxel

Albumin-Bound Paclitaxel

Atezolizumab

Carboplatin

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Immunoglobulins, Intravenous

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Glucosamine

Induction Treatment:

Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals.

Concurrent Chemotherapy (CT)-Radiotherapy Treatment:

Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet.

After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment.

Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy.

Maintenance with Atezolizumab:

Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.

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

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.

Placlitaxel

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.

Eva Pereira

María Guirado, MD

Ainhoa Hernández, MD

Delvys Rodriguez, MD

Rosario García Campelo, MD

Ana López, MD

Mariano Provencio, MD

Bartomeu Massuti, MD

Ivana Sullivan, MD

Laia Vilà, MD

Mª Ángeles Sala, MD

Joaquim Bosch, MD

Ana Laura Ortega Granados, MD

Ana Laura Ortega Granados, Md

Begoña Campos, MD

Jacobo Rogado, MD

Carlos Aguado, MD

Manuel Dómine, MD

Miriam Dorta, MD

Karmele Areses, MD

Karmele Areses

Raquel Marsé, MD

Amelia Insa, MD

Ana Blasco, MD

Rafael López, MD

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

This is an open-label, non-randomized, phase II multi-centre controlled clinical trial.The total sample size is 51 patients. The population to be included are non-resectable stage IIIA-IIIB non-small cell lung cancer patients.

Patients randomised will receive induction treatment (Atezolizumab 1200mg+ Carboplatin AUC5+Paclitaxel 200 mg/m2 for 3 cycles) and concurrent chemotherapy (CT) -radiotherapy treatment for 3 cycles. At the end of concurrent treatment Atezolizumab 1200mg maintenance treatment will start and will be administered for 12 months (16 cycles).

The primary objective is to assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

PFS are defined as the time from inclusion until objective tumor progression or death.

Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1.5 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.

Design: Open-label, non-randomized, phase II multi-centre controlled clinical trial.

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

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

To assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.PFS is defined as the time from inclusion until objective tumor progression or death.

To evaluate the ORR of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.

To evaluate the Overall survival (OS) rate at 12 and 24 months of the treatment.

To evaluate the sites of first relapse or progression

Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

Fundación GECP

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