Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (NCT04223596) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients
Spain33 participantsStarted 2020-05-04
Plain-language summary
This is an open-label, non-randomised, phase II, exploratory, multi-country and multi-centre clinical trial. Chemotherapy-naïve patients with EML4-ALK rearrangement and with locally advanced or metastatic non-small cell lung cancer patients will be selected.
Patients enrolled in the study will receive brigatinib 90mg for the first 7 days (D 1-7 at cycle 1) and then 180mg daily thereafter for QW4 cycles of duration (28 days ±3days).
Brigatinib will be administered until progression disease, unacceptable toxicity, patient or physician decision to discontinue or death.
Brigatinib may continue beyond disease progression per RECIST v1.1 until loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue, or death as per SmPC recommendations.
Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 4-6 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 1 year after the end of treatment independently of the cause of end of treatment. The study will end once survival follow-up has concluded.
The trial will end with the preparation of the final report, scheduled for 5.5 years after the inclusion of the first patient approximately.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥ 18 years old
✓. ECOG performance status of 0-2
✓. Histologically or cytologically confirmed, Stage IIIB or IV NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, that is ALK+
✓. Patients who have documented locally ALK rearrangement by one of the following methods:
✓. a positive result from the Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit; or
✓. IHC with VENTANA ALK (D5F3) CDx assay
✓. No prior treatment for Stage IIIB or IV non-squamous NSCLC.
✓. Having a life expectancy ≥ 3 months
Exclusion criteria
✕. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene.
✕
What they're measuring
1
Overall response rate (ORR)
Timeframe: From date of randomization until the date of first documented progression or date of death, whichever came first, assessed up to 60 months
✕. 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, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT)
✕. 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.