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
Study ID
NCT07247786
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biological: Fecal Microbiota Transplantation — BIOLOGICAL
    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 — DRUG
    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 — DRUG
    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) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 15, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm (Durvalumab + chemotherapy + FMT capsules)
    The treatment begins with a dose of antibiotics and a fecal microbiota transplant (FMT). Neoadjuvant/Induction Treatment: Patients will receive intravenous (IV) Durvalumab in combination with IV Paclitaxel and Carboplatin, the latter administered at the end of the Paclitaxel infusion. Patients must discontinue study treatment if there is evidence of disease progression that precludes surgery. Patients with stable disease or partial response may still be considered for surgery. Surgery: After the induction treatment, each patient will be evaluated by a multidisciplinary team at their respective hospital to determine surgical eligibility. Adjuvant Treatment: Patients with R0 resection confirmed by surgical pathology after surgery will receive adjuvant treatment with IV Durvalumab for several cycles.
  • Active Comparator: Control Arm (Durvalumab + chemotherapy)
    Neoadjuvant/Induction Treatment: Patients will receive intravenous (IV) Durvalumab in combination with IV Paclitaxel and Carboplatin, the latter administered at the end of the Paclitaxel infusion. Patients must discontinue study treatment if there is evidence of disease progression that precludes surgery. Patients with stable disease or partial response may still be considered for surgery. Surgery: After the induction treatment, each patient will be evaluated by a multidisciplinary team at their respective hospital to determine surgical eligibility. Adjuvant Treatment: Patients with R0 resection confirmed by surgical pathology after surgery will receive adjuvant treatment with IV Durvalumab for several cycles.

Primary Outcome Measure

Pathological Complete Response (pCR) rate [ Time Frame: From date of randomization until the date of last follow up, assessed up to 24 months ]

Central Contacts

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