UnknownNot Applicable

A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2

15 participantsStarted 2022-06-30

Plain-language summary

At present, the main characteristics of the enrolled population in the clinical study of HER2-mutated non-small cell lung cancer are the YVMA mutation type. There are no relevant clinical trials specifically targeting rare mutation types. Pyrotinib has been approved for the treatment of HER2-positive advanced breast cancer in China, and pyrotinib has shown good development prospects in the treatment of advanced non-small cell lung cancer. The purpose of this study is to observe the efficacy and safety of pyrotinib maleate in patients with HER2 rare mutation in advanced non-small cell lung cancer.

Who can participate

Age range18 Years – 70 Years

SexALL

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

✓. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
✓. Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);
✓. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
✓. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min;
✓. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
✓. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN), and subjects with liver metastases should be ≤ 5×ULN;
✓. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
✓. Urine protein \<2+; if urine protein ≥2+, the 24-hour urine protein quantification shows that protein must be ≤1g;

What they're measuring

ORR

Timeframe: 2 Year

Trial details

NCT IDNCT05411276

SponsorBeijing Chest Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

Contact for this trial

Ying Hu, Doctor

010-89509304 huying@bjxkyy.cn

View on ClinicalTrials.gov More HER2 Mutant Non-small Cell Lung Cancer trials