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NOT YET RECRUITING
NCT07247786
PHASE2

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

View on ClinicalTrials.gov

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

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).

DRUG

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.

DRUG

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

DRUG

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