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Poop pills could supercharge lung cancer therapy

NCT ID NCT07247786

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether fecal transplants from immunotherapy responders can improve outcomes in stage II-III non-small cell lung cancer. 68 patients will receive either standard treatment (Durvalumab + chemotherapy) or the same plus fecal transplant capsules. The main goal is to see if the transplant increases the rate of complete tumor disappearance after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fecal microbiota transplant (FMT) capsules
What this could lead to
If it works, this could point toward a way to boost the effectiveness of standard lung cancer therapy by using healthy gut bacteria from patients who responded well to immunotherapy.
What could go wrong
This is a small, early-phase trial (68 patients) testing safety and feasibility first. The approach is experimental, and it is unknown if the transplant will meaningfully improve outcomes or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, La Coruña, 15706, Spain

  • Complexo Hospitalario Universitario De Vigo

    Vigo, Vigo, 36204, Spain

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040, Spain

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital General Universitario De Elche

    Elche, Alicante, 03203, Spain

  • Hospital General Universitario Morales Meseguer

    Murcia, Murcia, 30008, Spain

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010, Spain

  • Hospital Universitari Quiron Dexeus

    Barcelona, Barcelona, 08028, Spain

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    Granada, Granada, 18007, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Regional de Málaga

    Málaga, Málaga, 29010, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041, Spain

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

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