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

Summary

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.

Eligibility

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.
* Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
* 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
* Pleural or pericardial effusion
* 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.
* Symptomatic neuropathy grade \> 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
* Severe infections within 4 weeks prior to be included in the study

Conditions5

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