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Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)
Sponsor: Fundación GECP
Summary
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.
Official title: Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-03-15
Completion Date
2031-12-30
Last Updated
2025-12-30
Healthy Volunteers
No
Interventions
Biological: Fecal Microbiota Transplantation
Patients who are going to be donors must have been treated with neoadjuvant chemoimmunotherapy as part of the NADIM studies and must have achieved a pathological complete response (pCR). Additionally, they must be free of disease and complications such as a second tumor or treatment-related toxicity. Samples must be collected from patients who achieved pCR after surgery. Patients in the Experimental Arm will receive an antibiotic treatment, followed by the administration of capsules as part of the fecal microbiota transplant (FMT).
Durvalumab
Durvalumab is a human monoclonal antibody of the immunoglobulin G1 kappa (IgG1κ) subclass that inhibits binding of programmed cell death ligand (PD-L1). Durvalumab (MEDI4736) binds with high affinity and specificity to human PD-L1 and blocks its interaction with PD-1 and CD80. Pharmaceutical form: Concentrate for solution for infusion (sterile concentrate).Clear to opalescent, colorless to light yellow solution, with no visible particles. The solution has an approximate pH of 6.0 and an osmolality of approximately 400 mOsm/kg. Durvalumab will be administered as part of both the neoadjuvant and adjuvant phases of the study.
Paclitaxel
Neoadjuvant / induction treatment: Durvalumab Paclitaxel Carboplatin Neoadjuvant / induction treatment: 4 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 200mg/m2 over 3 hours
Carboplatin (AUC 6)
Neoadjuvant / induction treatment: Durvalumab Paclitaxel Carboplatin\* \*Infusion at the end of the Paclitaxel infusion. Neoadjuvant / induction treatment 4 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.
Locations (20)
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Hospital General Universitario De Elche
Elche, Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Quiron Dexeus
Barcelona, Barcelona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Granada, Spain
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario 12 De Octubre
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Spain
Hospital Universitario Regional de Málaga
Málaga, Málaga, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Hospital Clínico de Valencia
Valencia, Valencia, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Complexo Hospitalario Universitario De Vigo
Vigo, Vigo, Spain