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 - APOLO

Fundación GECP0 sites51 target enrollmentSeptember 1, 2021

Conditionson small cell lung cancer MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTecentriq

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on small cell lung cancer
Sponsor: Fundación GECP
Enrollment: 51
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 1, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fundación GECP

Eligibility Criteria

Inclusion Criteria

•1\.Male or female, aged \= 18 years old and \= 75 years
•2\.ECOG performance status of 0 or 1\.
•3\.Histologically or cytologically confirmed, non\-resectable Stage IIIA\-IIIB non\-squamous NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
•4\.PET\-CT and brain CT or MRI at baseline to confirm the absence of distant disease
•5\.Mediastinal involvement could be considered without histological confirmation when no margin can be distinguished in the lymph node mass.
•6\.No prior treatment with anti\-neoplasic drugs or thoracic radiotherapy for Stage IIIA\-IIIB non\-squamous NSCLC.
•7\.Patients who have received prior neo\-adjuvant, adjuvant chemotherapy with curative intent for non\-metastatic disease must have experienced a treatment\-free interval of at least 6 months from enrollment since the last chemotherapy.
•8\.Presence of at least one measurable disease by CT\-SCAN, as defined by RECIST v1\.1\.
•9\.Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to enrollment:
•Neutrophils \= 1500 cells/µL without granulocyte colony\-stimulating factor support.

Exclusion Criteria

•1\.Patients with a sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene, ALK fusion oncogene
•2\.Known STK\-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
•3\.Weight loss \>10% within the previous 3 months.
•4\.Malignant pleural effusion or pericardial effusion: both will be considered as suggestive of metastatic disease. Also excluded those with negative cytology but being exudates.
•Patients with non\-visible by thoracic X\-Ray pleural effusion or too small to be safely punctioned could be included.
•5\.Malignancies other than NSCLC within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 3\-year OS \> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous\-cell skin cancer, localized prostate cancer treated with radiotherapy or surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent).
•6\.Women who are pregnant, lactating, or intending to become pregnant during the study.
•7\.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the Atezolizumab formulation.
•8\.History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain\-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
•9\.History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug\-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.