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 IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002369-36-ES
• Lead Sponsor: Fundación GECP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified