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. MIGRANT GECP 24/02

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521251-24-00

Acronym

GECP 24/02_MIGRANT

Enrollment

Registered

2025-09-08

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small cell lung cancer (NSCLC)

Brief summary

The primary objective is to evaluate the pathological Complete Response (pCR) rate in the intention to treat population (ITT population) Pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes after surgery.

Detailed description

1. Progression free survival (PFS) rate at 12 and 24 months, 2. Overall survival (OS) rate at 12 and 24 months of treatment, 3. Resectability rate (%), 4. Proportion of R0 resections (%), 5. Safety and tolerability of the treatment: Adverse events graded according to CTCAEv 5.0

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion

DRUGSpiraxin 200 mg comprimidos recubiertos con película

DRUGCarboplatino Teva 10 mg/ml Concentrado para solución para perfusión

DRUGPaclitaxel Teva 6 mg/ml concentrado para solución para perfusión EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary objective is to evaluate the pathological Complete Response (pCR) rate in the intention to treat population (ITT population) Pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes after surgery.	—

Secondary

Measure	Time frame
1. Progression free survival (PFS) rate at 12 and 24 months, 2. Overall survival (OS) rate at 12 and 24 months of treatment, 3. Resectability rate (%), 4. Proportion of R0 resections (%), 5. Safety and tolerability of the treatment: Adverse events graded according to CTCAEv 5.0	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026