Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NS… (NCT07247786) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)
Spain68 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 failu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological Complete Response (pCR) rate
Timeframe: From date of randomization until the date of last follow up, assessed up to 24 months