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Could a cancer drug slow lung scarring? new trial tests anlotinib for IPF

NCT ID NCT05828953

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether anlotinib, a drug currently used for cancer, can help people with idiopathic pulmonary fibrosis (IPF) or progressive fibrosis-interstitial lung disease. The study involves 30 adults aged 40-85 and measures changes in lung function over 52 weeks. Participants take anlotinib or a placebo daily in a 2-weeks-on, 1-week-off cycle.

What this could mean

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

Active substance
Anlotinib (a drug that may slow lung scarring)
What this could lead to
If it works, this could point toward a new treatment to slow lung function decline in people with IPF or related lung scarring diseases.
What could go wrong
This is a small, early Phase 2 trial with only 30 participants. It may not show clear benefit, and anlotinib has not been proven safe or effective for these conditions yet.

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 30 people

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

Started

Sep 2021

Expected to finish

Sep 2026

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

40 to 85 years

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. The participants voluntarily joined the study and signed an informed consent form. They showed good compliance throughout the study. 2. The study includes individuals aged 40-85 years old, of any gender, with an expected lifespan of over 1 year. 3. Subjects who meet either of the following two criteria: a. HRCT results confirming IPF diagnosis within the past 5 years and HRCT results within the past 12 months showing a range of parenchymal fibrotic changes between ≥10% and \<50%, with less than 25% honeycombing change in the lung, and no other facilitating factors (e.g. asbestos exposure, allergic pneumonia, systemic sclerosis, rheumatoid arthritis) as detailed in Annex 1A. b. PF-ILDs: Patients with characteristics of fibrotic lung disease (see Annex 1B), and at least one of the following diagnostic criteria is met: i. Relative decline in FVC% predicted by ≥10% within 6 months; ii. Relative decline in FVC% predicted by ≥5-10% with worsening respiratory symptoms, or an increase in the degree of fibrosis on chest HRCT; ii. Worsening respiratory symptoms combined with an increase in the degree of fibrosis on chest HRCT; 4. Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin) between 30% and 80% of predicted value; 5. Forced vital capacity (FVC) ≥ 45% predicted; 6. The 6MWT distance is ≥ 150 meters 7. Arterial partial pressure of oxygen (PaO2) ≥ 60 mmHg (measured at sea level atmospheric pressure, at rest, and breathing room air) 8. "Major organ functions are good, and meet the following criteria: a. Standard blood routine examination (not corrected by blood transfusion or hematopoietic growth factor drugs in the past 7 days): hemoglobin (HGB) ≥ 90 g/L; absolute neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; b. Biochemical examination should meet the following criteria: total bilirubin (TBL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min; c. Coagulation function or thyroid function examination should meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (not receiving anticoagulation therapy) or stable use of anticoagulants in the 2 weeks before enrollment; d. Thyroid-stimulating hormone (TSH) ≤ ULN after standard treatment; if abnormal, T3 and T4 levels should be investigated and can be enrolled if T3 and T4 levels are normal. e. Echocardiography evaluation: Left ventricular ejection fraction (LVEF) ≥50% 9. Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study. Exclusion Criteria: 1. Patients with acute exacerbation of IPF/PF-ILDs.; 2. Multiple factors that affect oral medication (such as dysphagia, chronic diarrhea, and intestinal obstruction) 3. Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment. 4. Long-standing non-healing wound or fracture. 5. Patients who have experienced thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism, within the past 6 months, or those with other bleeding tendencies. 6. Subjects with any severe or uncontrolled comorbidities or undergoing immunotherapy, such as: 1. Blood pressure remains uncontrolled even after antihypertensive therapy (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); 2nd-degree myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥450ms (men), QTc ≥470ms (women)) or 2nd-degree congestive heart failure (New York Heart Association (NYHA) classification); pulmonary or systemic infections within 4 weeks before enrollment; 2. Severe pulmonary arterial hypertension (systolic pulmonary artery pressure (SPAP) ≥70mmHg); 3. Renal failure requiring hemodialysis or peritoneal dialysis; 4. History of immune deficiency diseases, including HIV-positive or other acquired or congenital immune deficiency diseases, or history of organ transplantation; 5. Known clinically significant liver disease history, including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\>2500 copies/mL or \>500IU/mL, and greater than the upper limit of normal); known hepatitis C virus (HCV) infection and positive HCV RNA (\>1×103 copies/mL), or other decompensated liver diseases; 6. Fasting blood glucose (FBG) \>10mmol/L after administration of hypoglycemic drugs (poor blood glucose control patients); 7. Urine routine test indicates urine protein ≥+, and 24-hour urine protein quantitation is confirmed to be \>1.0g. 7. Received high-dose steroids (e.g. prednisone \>15mg/kg) within 1 month prior to randomization; 8. Use of immunosuppressants within 1 month prior to randomization after enrollment; 9. Long-term use (\>1 week) of drugs such as amiodarone that may cause pulmonary fibrosis prior to enrollment; 10. Received interferon, N-acetylcysteine (\>1800mg), or other anti-fibrotic drugs within 1 month prior to randomization 11. Prior treatment with nintedanib or pirfenidone is allowed only if discontinued at least 28 days before randomization; patients with a washout period of less than 28 days are excluded. 12. Participation in other drug trials within 3 months prior to randomization 13. The researcher considers any ineligible candidates.

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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.

Contacts and locations

Locations

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

More trials for these conditions

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