ALK+ non-small cell lung cancer MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Alunbrig
Product Name: Brigatinib
Product Code: AP26113
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BRIGATINIB
CAS Number: 1197953-54-0
Current Sponsor code: AP26113
Conce
Sponsors
Fundación GECP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged = 18 years old 2. ECOG performance status of 0-2 3. Histologically or cytologically confirmed, Stage IIIB or IV NSCLC 4. Patients who have documented locally ALK rearrangement 5. No prior treatment for Stage IIIB or IV non-squamous NSCLC. 6. Having a life expectancy = 3 months 7. 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. 8. Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable 9. Patients with at least 1 measurable lesion, as defined by RECIST v1.1 10. 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 11. Adequate hematologic and organ function 12. 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. 13. Willingness and ability to comply with scheduled visits and study procedures 14. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK-1 Ligand alteration, MDM2 amplification or ROS1 translocations. 2. Patients that received any prior TKI, including ALK-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease 3. Patients that have received chemotherapy or radiation within 14 days of first dose of study drug. 4. 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 5. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed. 6. Malignancies other than NSCLC within 3 years prior to enrollment 7. Women who are pregnant, lactating, or intending to become pregnant during the study. 8. Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib 9. 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. 10. Have uncontrolled hypertension 11. Positive test for HIV. A and patients with active hepatitis B or active tuberculosis 12. Severe infections within 2 weeks prior to be included in the study 13. Have significant, uncontrolled or active cardiovascular disease 14. Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: To evaluate the Overall response rate (ORR) RECIST V1.1 criteria will be used. CT-SCANs will be done every 12 weeks during the treatment to evaluate the response to the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Duration of response (DOR) - Intracranial overall response rate - PFS rate at 1 year and 2 years - Overall Survival (OS) rate at 1 year and 2 years - Safety and tolerability of brigatinib;Timepoint(s) of evaluation of this end point: DOR, PFS: from the start of the treatment to date of progression OS: from the start of the treatment to date of death or last follow up Safety and tolerability of brigatinib: at the end of the trial | — |
Countries
Portugal, Spain
Contacts
Public ContactEva Pereira
Fundación GECP
Outcome results
None listed