BRIGATINIB for Non-small cell lung cancer (ALK-positive)

Inclusion criteria

• {"criterion_text":"- Male or female, aged equal or greater ≥18 years old\n- 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\n- Adequate hematologic and organ function\n- 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.\n- Willingness and ability to comply with scheduled visits and study procedures\n- For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment)\n- ECOG performance status of 0-2\n- Histologically or cytologically confirmed, Stage IIIB or IV NSCLC\n- Patients who have documented locally ALK rearrangement\n- No prior treatment for Stage IIIB or IV non-squamous NSCLC.\n- Having a life expectancy ≥ 3 months\n- 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.\n- Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable\n- Patients with at least 1 measurable lesion, as defined by RECIST v1.1"}

Exclusion criteria

• {"criterion_text":"- Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK-1 Ligand alteration, MDM2 amplification or ROS1 translocations.\n- Have uncontrolled hypertension\n- Positive test for HIV. A and patients with active hepatitis B or active tuberculosis\n- Severe infections within 2 weeks prior to be included in the study\n- Have significant, uncontrolled or active cardiovascular disease\n- Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures\n- Patients that received any prior TKI, including ALK-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease\n- Patients that have received chemotherapy or radiation within 14 days of first dose of study drug.\n- 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\n- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed.\n- Malignancies other than NSCLC within 3 years prior to enrollment\n- Women who are pregnant, lactating, or intending to become pregnant during the study\n- Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib\n- 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."}

Primary endpoints

• {"endpoint_text":"- Overall response rate","definition_or_measurement_approach":"Overall response rate (ORR) of brigatinib as measured by investigator; overall response will be assessed per RECIST V1.1 criteria."}

Secondary endpoints

• {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":"Assessed according to RECIST v1.1 as specified in secondary objectives."}
• {"endpoint_text":"- Intracranial overall response rate","definition_or_measurement_approach":"Assessment of intracranial ORR and intracranial time to progression as specified in secondary objectives."}
• {"endpoint_text":"- PFS rate at 1 year and 2 years","definition_or_measurement_approach":"Progression-free survival (PFS) rate at 1 and 2 years assessed by RECIST v1.1."}
• {"endpoint_text":"- Overall Survival (OS) rate at 1 year and 2 years","definition_or_measurement_approach":"Overall survival (OS) rate at 1 and 2 years as specified in secondary endpoints."}
• {"endpoint_text":"- Safety and tolerability of brigatinib","definition_or_measurement_approach":"Safety and tolerability assessed as described in study safety objectives (standard safety assessments as per protocol)."}

Spain

Earliest CTIS Part Ii Submission Date

05-03-2024

Latest Decision Or Authorization Date

11-03-2024

Processing Time Days

6

Number Of Sites

15

Number Of Participants

33

Primary sponsor

Full Name

Fundacion GECP

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain