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

Phase 1

Conditions: ALK+ non-small cell lung cancer
MedDRA version: 20.0Level: LLTClassification code: 10025055Term: Lung cancer non-small cell stage IV Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-511317-38-00

Lead Sponsor: Fundacion GECP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK-1 Ligand alteration, MDM2 amplification or ROS1 translocations., Have uncontrolled hypertension, Positive test for HIV. A and patients with active hepatitis B or active tuberculosis, Severe infections within 2 weeks prior to be included in the study, 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, 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, Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed., Malignancies other than NSCLC within 3 years prior to enrollment, Women who are pregnant, lactating, or intending to become pregnant during the study, Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib, 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the Overall response rate (ORR) of brigatinib as measured by investigator. Overall response will be assessed per RECIST V1.1 criteria;Secondary Objective: To evaluate the efficacy of brigatinib as measured by investigator. Assessed as duration of response (DOR) according to RECIST v1.1., To evaluate the efficacy of brigatinib as measured by investigator. Assessed as time on treatment according to RECIST v1.1., To evaluate the intracranial overall response rate (ORR) and the intracranial time to progression, To evaluate the PFS rate at 1 year and 2 years of treatment with brigatinib by RECIST v1.1, To evaluate the Overall Survival (OS) rate at 1 year and 2 years of treatment with brigatinib, To evaluate the safety and tolerability of brigatinib.;Primary end point(s): Overall response rate

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Duration of response (DOR);Secondary end point(s):Intracranial overall response rate;Secondary end point(s):PFS rate at 1 year and 2 years;Secondary end point(s):Overall Survival (OS) rate at 1 year and 2 years;Secondary end point(s):Safety and tolerability of brigatinib