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Can a simple pill prevent a common side effect of targeted lung cancer therapy?

NCT ID NCT07418879

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether taking leucogen (a drug that raises white blood cell counts) from the start can prevent low white blood cells in people with RET fusion-positive non-small cell lung cancer who are taking pralsetinib. About 25 people who have not had prior treatment will take both drugs for up to 3 months. The main goal is to see how many develop low white blood cell counts during the first month.

What this could mean

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

Active substance
pralsetinib and leucogen
What this could lead to
If it works, this could show that taking leucogen alongside pralsetinib helps prevent a common side effect (low white blood cells), making treatment safer and more tolerable.
What could go wrong
This is a very small, early real-world study with only 25 people and no comparison group. It is not designed to prove pralsetinib works, only to see if leucogen reduces side effects. Results may not apply to everyone.

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 25 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 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)Aged ≥ 18 years, male or female; * (2)Treatment-naive patients with histopathologically confirmed locally advanced or metastatic lung adenocarcinoma that is unresectable and not eligible for curative radiotherapy; * (3)RET fusion-positive; * (4)Subjects with locally advanced (determined by the investigator as unsuitable for surgery or radiotherapy) or metastatic NSCLC who have not received any systemic anti-tumor treatment; * (5)Laboratory tests indicating adequate organ function in subjects, including:a. Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet Count (PLT) ≥ 100×10⁹/L; Hemoglobin (HGB) ≥ 90g/L;b. Without liver metastasis, AST and ALT ≤ 3× upper limit of normal (ULN); with liver metastasis, AST and ALT ≤ 5× ULN;c. Serum Total Bilirubin (TBIL) ≤ 1.5× ULN; for patients with Gilbert's syndrome, TBIL ≤ 3× ULN is allowed;d. Creatinine Clearance (CrCL) ≥ 40 ml/min (calculated by the Cockcroft-Gault formula); * (6)ECOG Performance Status score of 0-2 at screening, with no significant disease progression within 2 weeks before screening; * (7)Expected survival \> 12 weeks after the first dose; * (8) Reproductive-aged female subjects are not pregnant and have no plans for pregnancy. Both reproductive-aged female and male subjects agree to use effective contraceptive measures during the study and within 6 months after drug discontinuation; * (9) Understand and voluntarily participate in the study, and sign the informed consent form.) Exclusion Criteria: * (1) Histological or cytological examination indicates squamous cell-predominant non-small cell lung cancer (NSCLC), small cell lung cancer, neuroendocrine carcinoma, or other similar malignancies; * (2) Having received the following treatments:a. Major surgery performed within 4 weeks before the first dose or planned to be performed during the trial, excluding procedures such as vascular access establishment, mediastinoscopy, or thoracoscopy-guided biopsy;b. Use of strong CYP3A4 inhibitors within 7 days before the first dose or strong CYP3A4 inducers within 21 days before the first dose; use of traditional Chinese medicines (TCMs) or TCM preparations indicated for anti-tumor therapy, or TCMs/TCM preparations with adjuvant anti-tumor effects within 2 weeks before the first dose or expected to be used during the trial; * (3) Patients with spinal cord compression or symptomatic leptomeningeal metastasis; * (4) Patients with symptomatic and unstable pleural effusion or ascites; those whose clinical symptoms are stable for at least 14 days after thoracentesis or paracentesis may be enrolled; * (5) History of other malignant tumors or current concurrent other malignant tumors (excluding malignant tumors that have been cured by radical surgery and recurrence-free for 5 years, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and papillary thyroid carcinoma); * (6) Past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment; or clinical manifestations suggestive of interstitial lung disease; * (7) Having severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (NYHA cardiac function classification III-IV), unstable angina pectoris, myocardial infarction within 1 year, active hemorrhage, and other diseases; * (8) Resting QT interval (QTc) \> 470 msec detected by clinical electrocardiogram (ECG) screening; * (9) Clinically significant QT interval prolongation or other arrhythmias or clinical conditions that the investigator believes may increase the risk of QT interval prolongation, such as complete left bundle branch block, third-degree atrioventricular block, congenital long QT syndrome, severe hypokalemia, or concurrent use of drugs that may prolong the QT interval; * (10) Severe gastrointestinal dysfunction or other diseases that may affect the intake, transport, or absorption of study drugs; * (11) Patients with infectious diseases requiring intravenous medication; * (12) Known or suspected allergy to Pralsetinib or other components of its preparation; * (13) Female subjects who are pregnant, lactating, or planning to become pregnant during the study, or female spouses of male subjects planning to become pregnant during the study; * (14) Subjects with poor compliance who cannot adhere to the study procedures, restrictions, or requirements; * (15) Other conditions that the investigator deems unsuitable for participation in the 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

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  1. 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 ↗

  2. A doctor treating you

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