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 range18 Years
SexALL
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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…
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