Non Small Cell Lung CancerPhase 2MIGRANTNCT07247786
Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)
A Phase 2 study testing Biological: Fecal Microbiota Transplantation, Durvalumab and Paclitaxel in people with Non Small Cell Lung Cancer and Respiratory Tract Neoplasm, run by Fundación GECP at 20 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Respiratory Tract Neoplasm
- What is being tested?
- Biological: Fecal Microbiota Transplantation, Durvalumab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 20 sitesSpain
- Study dates
- 15 Sep 2026to 30 Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Patients with a life expectancy ≥12 weeks.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
Who cannot join
- 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
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- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Spain20 sites
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Quiron Dexeus
Barcelona, Barcelona, 08028
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Hospital General Universitario De Elche
Elche, Alicante, 03203
Hospital Universitario Clínico San Cecilio
Granada, Granada, 18007
Silvia Sequero, MD
Silvia Sequero
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario 12 De Octubre
Madrid, Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Regional de Málaga
Málaga, Málaga, 29010
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, La Coruña, 15706
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Hospital Universitario La Fe
Valencia, Valencia, 46026
Complexo Hospitalario Universitario De Vigo
Vigo, Vigo, 36204
About this study
Official title: 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.
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)
Read more
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.
Read the detailed description
This is a randomized, phase II, multi-centre clinical trial stratified according to PDL1 status (≥50 % or <50%), and Akkermansia positive vs negative.
In the pre-treatment phase, donors will be selected for preparing the fecal microbiota transplant with their samples.
After that, patient's candidate with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer to study will be randomized in two different arms.
In the Experimental arm, after randomization, patients will receive treatment with Rifaximin. Once done, the patient will start neoadjuvant treatment with Durvalumab IV + Chemotherapy for several cycles.
In the Control arm, after randomization patients will receive neoadjuvant treatment with Durvalumab IV + Chemotherapy for several cycles.
After neoadjuvant/induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is a candidate for surgery or not.
Patients that are R0 confirmed by surgical pathology evaluation after surgery will receive Adjuvant treatment with Durvalumab IV.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
The primary objective is to evaluate the pathological Complete Response (pCR) rate in the intention to treat population (ITT population)
The total trial duration will be 6.5 years approximately.
- Being tested
- Biological: Fecal Microbiota Transplantation, Durvalumab, Paclitaxel, Carboplatin (AUC 6)
- Keywords
- Non small cell lung cancer, Fecal microbiota transplant, Inmune checkpoint inhibitor responder, Neoadjuvant treatment, Adjuvant treatment, Durvalumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: Fecal Microbiota TransplantationBiological
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).
DurvalumabDrug
Also called Imfinzi, MEDI4736
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.
PaclitaxelDrug
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Durvalumab; Drug: Paclitaxel; Drug: Carboplatin (AUC 6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate
Pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes after surgery.
Measured: From date of randomization until the date of last follow up, assessed up to 24 months
Secondary outcomes (5)
Progression free survival (PFS)
Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From date of randomization until the date of last follow up, assessed up to 24 months
Overall Survival (OS)
Overall survival (OS) defined as the time which begins at the start of treatment and up to the time of death or last follow up
Measured: From date of randomization until the date of last follow up, assessed up to 24 months
Resectability rate (%)
Resectability rate defined as the percentage of patients resected divided by the total number of patients who received neoadjuvant treatment
Measured: From date of randomization until the date of last follow up, assessed up to 24 months
Proportion of R0 resections (%)
Percentage of R0 resection will be calculated by dividing the total number of R0 resection patients by the total number of patients resected.
Measured: 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)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Measured: From the subject's written consent to participate in the study through 90 days after the final administration of the drug.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Sep 2026 (estimated)
- Primary completion30 Dec 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Study chair, President of Grupo Español de Cáncer de Pulmón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247786
- Sponsor's protocol ID
- GECP 24/02_MIGRANT
- Other IDs
- 2025-521251-24-00, 2025
- Acronym
- MIGRANT
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07247786
- Acronym / sponsor ID
- MIGRANT / GECP 24/02_MIGRANT
- Keywords
- Non small cell lung cancer, Fecal microbiota transplant, Inmune checkpoint inhibitor responder, Neoadjuvant treatment, Adjuvant treatment, Durvalumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, phase II, multi-centre clinical trial stratified according to PDL1 status (≥50 % or <50%), and Akkermansia positive vs negative.
In the pre-treatment phase, donors will be selected for preparing the fecal microbiota transplant with their samples.
After that, patient's candidate with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer to study will be randomized in two different arms.
In the Experimental arm, after randomization, patients will receive treatment with Rifaximin. Once done, the patient will start neoadjuvant treatment with Durvalumab IV + Chemotherapy for several cycles.
In the Control arm, after randomization patients will receive neoadjuvant treatment with Durvalumab IV + Chemotherapy for several cycles.
After neoadjuvant/induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is a candidate for surgery or not.
Patients that are R0 confirmed by surgical pathology evaluation after surgery will receive Adjuvant treatment with Durvalumab IV.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
The primary objective is to evaluate the pathological Complete Response (pCR) rate in the intention to treat population (ITT population)
The total trial duration will be 6.5 years approximately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (Durvalumab + chemotherapy + FMT capsules) | Experimental | Biological: Biological: Fecal Microbiota Transplantation, Drug: Durvalumab, Drug: Paclitaxel, Drug: Carboplatin (AUC 6)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. |
| Control Arm (Durvalumab + chemotherapy) | Active comparator | Drug: Durvalumab, Drug: Paclitaxel, Drug: Carboplatin (AUC 6)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: Fecal Microbiota TransplantationPatients 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). | Biological | Experimental Arm (Durvalumab + chemotherapy + FMT capsules) |
| DurvalumabAlso: Imfinzi, MEDI4736Durvalumab 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. | Drug | Control Arm (Durvalumab + chemotherapy), Experimental Arm (Durvalumab + chemotherapy + FMT capsules) |
| PaclitaxelNeoadjuvant / 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 | Drug | Control Arm (Durvalumab + chemotherapy), Experimental Arm (Durvalumab + chemotherapy + FMT capsules) |
| Carboplatin (AUC 6)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. | Drug | Control Arm (Durvalumab + chemotherapy), Experimental Arm (Durvalumab + chemotherapy + FMT capsules) |
Primary outcome
Pathological Complete Response (pCR) rate
Time frame: From date of randomization until the date of last follow up, assessed up to 24 months
Pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes after surgery.
5 secondary outcomes
Progression free survival (PFS)
Time frame: From date of randomization until the date of last follow up, assessed up to 24 months
Overall Survival (OS)
Time frame: From date of randomization until the date of last follow up, assessed up to 24 months
Resectability rate (%)
Time frame: From date of randomization until the date of last follow up, assessed up to 24 months
Proportion of R0 resections (%)
Time frame: 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)
Time frame: From the subject's written consent to participate in the study through 90 days after the final administration of the drug.]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariano Provencio, MD study chair
President of Grupo Español de Cáncer de Pulmón
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological: Fecal Microbiota Transplantation, Durvalumab and Paclitaxel in people with Non Small Cell Lung Cancer and Respiratory Tract Neoplasm, run by Fundación GECP at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Pereira (+34934302006, gecp@gecp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) rate (time frame: From date of randomization until the date of last follow up, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.