NCT07247786

Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)

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.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Fundación GECP · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, phase II, multi-centre clinical trial stratified according to PDL1 status (≥50 % or \<50%), and Akkermansia positive vs negative. In the pre-treatment phase, donors will be selected for preparing the fecal microbiota transplant with their samples. After that, patient's candidate with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer to study will be randomized in two different arms. In the Experimental arm, after randomization, patients will receive treatment with Rifaximin. Once done, the patient will start neoadjuvant treatment with Durvalumab IV + Chemotherapy for several cycles. In the Control arm, after randomization patients will receive neoadjuvant treatment with Durvalumab IV + Chemotherapy for several cycles. After neoadjuvant/induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is a candidate for surgery or not. Patients that are R0 confirmed by surgical pathology evaluation after surgery will receive Adjuvant treatment with Durvalumab IV. Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients) The primary objective is to evaluate the pathological Complete Response (pCR) rate in the intention to treat population (ITT population) The total trial duration will be 6.5 years approximately.

Conditions

• Non Small Cell Lung Cancer
• Respiratory Tract Neoplasm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2031-12-30
• Completion: 2031-12-30
• First posted: 2025-11-25
• Last updated: 2025-12-30

Locations

20 sites across 1 country: Spain