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Herbal hope: can a traditional decoction boost immunotherapy for Bone-Metastatic lung cancer?

NCT ID NCT05378334

Disease control Sponsor: Guangzhou University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding a traditional Chinese herbal decoction (HGXJT) to standard immunotherapy can help control lung cancer that has spread to the bones. About 82 adults with a specific type of lung cancer (non-small cell, without certain gene mutations) will receive either the herbal medicine or a placebo alongside their regular treatment. The main goal is to see if the combination improves disease control rates, with follow-up scans every few months.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 82 people

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

Started

Jun 2022

Expected to finish

Jan 2028

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 to 75 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. Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology. 2. Presence of bone metastases. 3. EGFR/ALK gene wild type. 4. No prior treatment with PD-1 inhibitors (combination or monotherapy) 5. Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy. 6. PS score (ECOG) ≤ 2 points 7. Normal hepatic and renal function. Normal hepatic function: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value(ULN), serum serum aspartate aminotransferase(AST) \& alanine aminotransferase(ALT) ≤ 2.5 times ULN Normal renal function: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min. 8. Presence of at least one assessable lesion. 9. Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance. Exclusion Criteria: 1. Unable to complete the baseline assessment form 2. Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies. 3. Pregnant or lactating women. 4. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs. 5. Combination of other uncontrolled tumors. 6. Combination of severe brain or mental illness that affects the patient's ability to self-report. 7. Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation). 8. Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer

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 Hospital of Traditional Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, China

More trials for these conditions

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