A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive … (NCT07418879) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC
25 participantsStarted 2026-02-05
Plain-language summary
This study is a single-arm, multicenter real-world clinical study designed to evaluate the safety and efficacy of Leucogen (a leukocyte-increasing agent) as a prophylactic treatment in patients with RET fusion-positive non-small cell lung cancer (NSCLC) who are being treated with Pralsetinib.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Cri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib