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Your gut bacteria might hold the key to lung cancer treatment

NCT ID NCT07752589

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study is exploring whether the bacteria in your gut can predict how well a certain type of lung cancer responds to treatment. Researchers are following 100 people with stage II-IIIB non-small cell lung cancer who are receiving chemoimmunotherapy before surgery. The goal is to see if the makeup of gut microbes is linked to how much the tumor shrinks or disappears, which could lead to more personalized treatment plans.

What this could mean

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

Active substance
Neoadjuvant chemoimmunotherapy (PD-1 inhibitor plus platinum-based chemotherapy)
What this could lead to
If gut bacteria predict treatment response, doctors might tailor lung cancer therapy based on a patient's microbiome, potentially improving outcomes.
What could go wrong
This is an observational study, so it won't prove cause and effect. The link between gut bacteria and treatment response may not be strong enough to guide clinical decisions.

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.

Participants

About 100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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.

Who is studied

Patients with stage IIA to IIIB non-small cell lung cancer (squamous or non-squamous subtype) who are planned to receive neoadjuvant immunotherapy combined with platinum-based doublet chemotherapy.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age between 18 and 80 years; 2. Newly diagnosed, driver gene-negative non-small cell lung cancer (NSCLC) confirmed by histopathology (Stage IIA-IIIB); 3. At least one measurable lesion as defined by RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 4. No prior systemic therapy or radiotherapy; 5. Eligible for surgical resection and suitable for neoadjuvant immunotherapy or chemotherapy as determined by multidisciplinary evaluation; 6. Signed written informed consent prior to study participation; 7. Adequate pulmonary ventilation and diffusion function confirmed by pre-enrollment pulmonary function test to allow for surgical resection. Exclusion Criteria: 1. Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments; 2. Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months; 3. Probiotic use within 3 months prior to enrollment; 4. Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis; 5. Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus; 6. Presence of a primary tumor in another organ; 7. Receipt of chemotherapy or any other cancer treatment prior to enrollment; 8. Confirmed brain metastases by contrast-enhanced MRI before enrollment; 9. Active or pre-existing autoimmune diseases; 10. Uncontrolled comorbidities including heart failure, uncontrolled hypertension, unstable angina, or interstitial lung disease; 11. Positive for hepatitis B surface antigen or detectable hepatitis C RNA requiring treatment; 12. Known history or positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 13. Pregnant or breastfeeding women; 14. Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.

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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

    1 site. 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

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.