This is a randomized, phase II, multi-centre clinical trial.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
Population: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer
In the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .
In the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.
After neoadjuvant/induction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.
The primary objective is to evaluate the pathological Complete Response (pCR) rate.
The total trial duration will be 6.5 years approximately.
Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIA, IIB, IIIA or IIIB (only T3N2) disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)
PET scan and brain CT or MRI at baseline to confirm the absence of distant disease
ECOG (Performance status) 0-1
Adequate hematologic and organ function.
Patients with known sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene or any variety of alterations of ALK oncogene.
Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
Weight loss >10% within the previous 3 months.
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.