Alectinib Pharmacokinetic in Patients With NSCLC

Ki vehet részt

• Both sexes
• ≥ 18 years old
• Pathologically confirmed diagnosis of NSCLC
• Stage IIIB - IV by the American Joint Committee of Cancer Version 8
• Recurrent disease (at least 180 days from curative intent treatment)
• ALK rearrangements tested by FDA-approved tests (IHQ or FISH)
• Karnofsky PS scale ≥ 70%
• Having received first-line treatment with anti-ALK inhibitors and one previous line of platinum-based chemotherapy
• Measurable disease as referred by RECIST version 1.1
• Symptomatic brain metastases could receive prior treatment with radiotherapy or surgery for at least two weeks before treatment initiation
• Asymptomatic brain metastases could not receive local therapy before study inclusion
• Negative highly sensitive pregnancy test (serum or urine) within 72 days before first dose intervention
• Sexually active patients should use a contraceptive method with a failure rate of less than 1% per year
• Signed written informed consent
• Adequate organ function (hematological, liver, and renal function)
• Life expectancy of at least 12 weeks

Ki nem vehet részt

• Treatment with other anti-cancer therapy
• Previous malignancies except for any carcinoma in-situ
• Any other serious condition or uncontrolled active infection, altered mental status, or psychiatric condition that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results
• Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel
• Active HIV infection
• Carcinomatous meningitis confirmed by a positive CRL cytology or highly suspicious brain MRI
• Participating in other clinical trials in the former four weeks
• Breastfeeding