RET fusion-positive locally advanced or metastatic non-small cell lung cancer(NSCLC)
Conditions
Interventions
Experimental group:Pralitinib 400mg, orally, once daily
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.>=18 years old, male or female; 2. Histopathologically confirmed, inoperative, and non-curative radiotherapy-naïve locally advanced or metastatic lung adenocarcinoma; 3. RET fusion positive; 4. Patients with locally advanced (not suitable for surgery or radiotherapy judged by the investigator) or metastatic NSCLC who have not undergone any systemic anti-tumor therapy; 5. Laboratory tests indicate that the subject has adequate organ function: including: (1) Absolute neutrophil value (ANC) >=1.5×10^9/L; Platelet count (PLT)>=100×10^9/L; Hemoglobin (HGB) >=90g/L; (2) AST and ALT=40 ml/min (according to the Cockcroft-Gault formula); 6. ECOG score of 0-2 at screening, no significant disease deterioration within 2 weeks before screening; 7. Expected survival after the first dose > 12 weeks; 8. Women of childbearing age who are not pregnant and have no pregnancy plan. Female subjects of childbearing age and male subjects agree to use effective contraception during the study and for 6 months after discontinuation; 9. Understand and voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
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: (1)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; (2)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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 Treatment-Related Adverse Events (TRAE), and Incidence of Dose Interruption/Reduction/Disc continuation;The grade and incidence of leukopenia and neutropenia at 2/3 months after the first administration of Pralsetinib;Patient-Reported Outcomes (PRO): Assessment using the EORTC QLQ-LC13 and EORTC QLQ-C30 scales;Median Time to Treatment Failure (median TTF); | — |
Countries
China
Contacts
Public ContactWang Jialei
Fudan University Shanghai Cancer Center
Outcome results
None listed