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

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.

Severe infections within 4 weeks prior to be included in the study.

Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study.

Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures.

Treatment with any other investigational agent with therapeutic intent within 28 days prior to initiation of study treatment.

Patients with uncontrolled comorbidities that may affect the clinical trial compliance.

Women who are pregnant or in the breastfeeding period or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.

Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

Patients must be informed that they are not allowed to donate blood during the treatment period of this clinical trial.

Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.

Receipt of a live attenuated vaccine within 30 days prior to the first dose of investigational product (IP).

Concurrent enrollment in another clinical study, except in cases where the study is observational (non-interventional) or the patient is in the follow-up phase of a previous interventional study.

What this study is about