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Inhaled gene therapy takes aim at lung nodules

NCT ID NCT07150416

Disease control Sponsor: The First Affiliated Hospital of Guangzhou Medical University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a gene therapy called Gendicine, given as a mist to breathe in, for people with multiple ground-glass lung nodules — spots that may turn into cancer. About 38 adults will receive the treatment and be monitored with CT scans to see if the nodules shrink or disappear. The goal is to find a safe, non-surgical way to control these precancerous growths.

What this could mean

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

Active substance
Gendicine (a gene therapy that delivers a healthy p53 gene via a modified cold virus, given as a mist to breathe in)
What this could lead to
If it works, this could offer a new way to shrink or clear precancerous lung nodules without surgery, potentially preventing lung cancer.
What could go wrong
This is a small, early-phase trial with only 38 people and no comparison group. The treatment may not shrink nodules and could cause side effects like lung irritation.

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 38 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Feb 2027

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: 1. Age ≥ 18 years. 2. CT scan confirms the presence of multiple ground-glass nodules (GGNs), with at least one nodule measuring between 0.5 cm and 3.0 cm in diameter. 3. At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology. 4. Life expectancy ≥ 12 weeks. 5. Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value). 6. Signed informed consent. Exclusion Criteria: 1. Pregnant or lactating women. 2. History of other active malignancies within the past 5 years. 3. Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST \> 3×ULN, Cr \> 1.5×ULN). 4. Uncontrolled systemic infection or immunodeficiency diseases. 5. Participation in another interventional clinical trial within 4 weeks prior to enrollment. 6. Known hypersensitivity to any component of the recombinant human p53 adenovirus injection.

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Conditions

The condition(s) this trial relates to.

lung neoplasm precancerous condition

As listed by the trial registrant

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

Lung neoplasms Multiple pulmonary ground-glass nodules Precancerous conditions

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

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

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