Malignant lung tumor
Conditions
Interventions
Observational group:None
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >=18 years; 2. Confirmed diagnosis of advanced lung adenocarcinoma by pathology; 3. Confirmed ALK gene rearrangement by next-generation sequencing, with possible co-occurrence of other driver gene mutations; 4. At least one measurable target lesion according to RECIST 1.1 criteria; 5. Disease progression, recurrence, or intolerable adverse reactions following prior lorlatinib targeted therapy, followed by treatment with Iruac (180 mg/day orally, once daily); 6. Expected survival time >12 weeks; 7. ECOG performance status score of 0–3; 8. Adequate major organ function; (hematology: i. hemoglobin >90 g/L [without transfusion within 14 days]; ii. absolute neutrophil count >1.5×10^9/L; iii. platelet count >90×10^9/L; biochemistry: i. total bilirubin =50 ml/min); 9. Signed informed consent form, good compliance, and willingness of patient and family to participate in survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Pathological type is any malignancy other than lung adenocarcinoma; 2. Prior treatment with Iruac; 3. Toxicity from prior anti-tumor therapy has not recovered to 10,000 copies/mL); 6. History of significant diseases prior to first dose, such as carcinomatous meningitis or history thereof, prior myocarditis, cardiomyopathy, malignant arrhythmia, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, or any other conditions deemed by the investigator as contraindications for enrollment; 7. Organ function prior to first study drug administration meets any of the following: • Absolute neutrophil count >2.5×ULN; aspartate aminotransferase >2.5×ULN; total bilirubin >1.5×ULN; or in patients with liver metastases, AST and/or ALT >5×ULN; • Serum creatinine >1.5×ULN and creatinine clearance 1.5 and partial thromboplastin time (APTT) >1.5×ULN; 8. Presence of any severe medical or psychiatric condition that may affect study compliance or interfere with interpretation of study results; 9. Pregnancy or lactation; 10. Incomplete case data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ( PFS );Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Objective response rate ( ORR );Treatment-related adverse reactions ( TRAE ); | — |
Countries
China
Contacts
Public ContactWang Fen
Peking University Shenzhen Hospital
Outcome results
None listed