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

Korábbi kezelés

• Weight loss >10% within the previous 3 months.
• Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.
• Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment
• Severe infections within 4 weeks prior to be included in the study

Más betegség

• Known hypersensitivity or allergy to atezolizumab formulation.
• History of autoimmune disease or lung disease
• Positive test for human immunodeficiency viruses (HIV)
• Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus.
• Active tuberculosis.

Egyéb

• Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.
• Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
• Pleural or pericardial effusion
• Symptomatic neuropathy grade > 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0

• Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)
• Confirm the absence of distant disease
• ECOG (Performance status) 0-1
• Adequate hematologic and organ function
• All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
• Adequate lung function
• Patients aged > 18 years
• For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
• For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception
• Oral contraception should always be combined with an additional contraceptive method
• Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
• Patient capable of proper therapeutic compliance and accessible for correct follow-up