Alectinib Pharmacokinetic in Patients With NSCLC

Inclusion Criteria

• •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