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

NCT07247786 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: GECP 24/02_MIGRANT2025-521251-24-00
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Non Small Cell Lung Cancer; Respiratory Tract Neoplasm

Keywords

Non small cell lung cancer; Fecal microbiota transplant; Inmune checkpoint inhibitor responder; Neoadjuvant treatment; Adjuvant treatment; Durvalumab

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) rate

  Pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes after surgery.

  From date of randomization until the date of last follow up, assessed up to 24 months

Secondary Outcomes (5)

• Progression free survival (PFS)

  From date of randomization until the date of last follow up, assessed up to 24 months

• Overall Survival (OS)

  From date of randomization until the date of last follow up, assessed up to 24 months

• Resectability rate (%)

  From date of randomization until the date of last follow up, assessed up to 24 months

• Proportion of R0 resections (%)

  From date of randomization until the date of last follow up, assessed up to 24 months

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  From the subject's written consent to participate in the study through 90 days after the final administration of the drug.]

Study Arms (2)

Experimental Arm (Durvalumab + chemotherapy + FMT capsules)

EXPERIMENTAL

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.

Biological: Biological: Fecal Microbiota Transplantation; Drug: Durvalumab; Drug: Paclitaxel; Drug: Carboplatin (AUC 6)

Control Arm (Durvalumab + chemotherapy)

ACTIVE COMPARATOR

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.

Drug: Durvalumab; Drug: Paclitaxel; Drug: Carboplatin (AUC 6)

Interventions

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.

Also known as: Imfinzi, MEDI4736

Control Arm (Durvalumab + chemotherapy); Experimental Arm (Durvalumab + chemotherapy + FMT capsules)

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

Control Arm (Durvalumab + chemotherapy); Experimental Arm (Durvalumab + chemotherapy + FMT capsules)

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.

Control Arm (Durvalumab + chemotherapy); Experimental Arm (Durvalumab + chemotherapy + FMT capsules)

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).

Experimental Arm (Durvalumab + chemotherapy + FMT capsules)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIA, IIB, IIIA or IIIB (only T3N2) disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)
• PET scan and brain CT or MRI at baseline to confirm the absence of distant disease
• ECOG (Performance status) 0-1
• Adequate hematologic and organ function.
• All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
• Adequate lung function: Forced Espiratoy Volumen in 1 second (FEV1) \>50% of normal volume and Difusion Capacity of the Lungs for Carbon Monoxide (DLCO) \>40% of normal value
• Patients aged ≥ 18 years at the time of study entry
• Body weight \> 30Kg (for durvalumab monotherapy)
• PDL1 analyzed (value in %)
• For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective forms of contraception that results in a low failure rate (\< 1% per year) when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment.
• For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment.
• Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. The same rules are valid for male patients involved in this clinical study if they have a partner of childbirth potential. Male patients must always use a condom.
• Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
• Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
• Presence of at least one measurable lesion by CT-SCAN, as defined by RECIST v1.1.

You may not qualify if:

• Patients with known sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene or any variety of alterations of ALK oncogene.
• Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
• Weight loss \>10% within the previous 3 months.
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
• Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy
• History of active primary immunodeficiency
• History of another primary malignancy.
• Active or prior documented autoimmune or inflammatory disorders.
• Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.
• Pleural or pericardial effusion.
• Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
• Positive test for HIV.
• Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
• Patients with history of allergy to study drug components/excipients.
• Active tuberculosis.

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (20)

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital General Universitario De Elche

Elche, Alicante, 03203, Spain

Location

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, Granada, 18007, Spain

Location

Complexo Hospitalario Universitario De Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

Location

Complexo Hospitalario Universitario De Vigo

Vigo, Vigo, 36204, Spain

Location

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms

Interventions

durvalumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Mariano Provencio, MD

  President of Grupo Español de Cáncer de Pulmón

  STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

+34934302006; gecp@gecp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (20)