Utility of analysis in blood of the evolution of the drug brigatinib for patients with lung cancer with ALK mutations

Prior treatment

• Severe infections within 2 weeks prior to be included in the study
• Patients that received any prior TKI, including ALK-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease
• Patients that have received chemotherapy or radiation within 14 days of first dose of study drug.
• Symptomatic CNS metastases (parenchymal or leptomeningeal) that are neurologically unstable or required an increasing dose of corticosteroids within 7 days prior to first dose of study drug
• Malignancies other than NSCLC within 3 years prior to enrollment
• Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib

Other illness

• Have uncontrolled hypertension
• Positive test for HIV. A and patients with active hepatitis B or active tuberculosis
• Have significant, uncontrolled or active cardiovascular disease
• Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures
• Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed.
• History of idiopathic pulmonary fibrosis, pulmonary interstitial disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.

Lab values

• Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK-1 Ligand alteration, MDM2 amplification or ROS1 translocations.

Other

• Women who are pregnant, lactating, or intending to become pregnant during the study

• Male or female, aged equal or greater ≥18 years old
• Normal QT interval (QT) on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤ 450 milliseconds (msec) in males of ≤ 470 msec in females
• Adequate hematologic and organ function
• All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
• Willingness and ability to comply with scheduled visits and study procedures
• For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment)
• ECOG performance status of 0-2
• Histologically or cytologically confirmed, Stage IIIB or IV NSCLC
• Patients who have documented locally ALK rearrangement
• No prior treatment for Stage IIIB or IV non-squamous NSCLC.
• Having a life expectancy ≥ 3 months
• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy.
• Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable
• Patients with at least 1 measurable lesion, as defined by RECIST v1.1