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
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.
Single group
Atezolizumab
DrugPatients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
Paclitaxel
DrugNeoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Paclitaxel: Intravenous infusion. 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.
Carboplatin
DrugNeoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin\* \*Infusion according to the standard of each center Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
Progression-free survival (PFS)
Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Resectability rate (%)
Resectability rate defined as the percentage of patients resected divided by the total number of patients who received neoadjuvant treatment.
Pathological complete response (pCR)
Pathological complete response (pCR) is defined as the absence of residual viable tumor on hematoxylin and eosin evaluation of the complete resected specimen
Overall survival (OS)
Overall survival (OS) defined as the time which begins at the start of treatment and up to the time of death or last follow up
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