Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)
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... [+16]
Patients with known sensitizing mutation or an amplification in the epidermal gr... [+26]