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 range18 Years
SexALL
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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…
What they're measuring
1
The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib