Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy
This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled. The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not. Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.
• 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