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Brigatinib 90 mg for the first 7 days and then 180 mg daily thereafter for QW4 cycles of duration (28 days +- 3 days)

Brigatinib 90 mg for the first 7 days (D1-7 at cycle 1) and then 180 mg daily thereafter for QW4 cycles of duration (28 days+-3 days)

Brigatinib

Mariano Provencio, MD

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.

Open-label, non-randomised, phase II, exploratory, multi-country and multi-centre clinical trial.

Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

Clinical Utility of Liquid Biopsy as a Tool to Assess the Evolution of Brigatinib Treated Patients With Non-small Cell Lung Cancer With EML4-ALK Translocation: an Exploratory Study

To evaluate the Overall response rate of brigatinib as measured by investigator. It will be assessed per RECIST v1.1 criteria. ORR is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.

To evaluate the efficacy of brigatinib as measured by investigator. Assessed as duration of response (DOR) according to RECIST v1.1

To evaluate the intracranial ORR defined as the proportion of patients with reduction in intracranial tumor

To evaluate PFS rate until first progression documented during the treatment with brigatinib by RECIST v1.1

To evaluate the OS defined as the lenght of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

Occurrence and severity of adverse events, with severity determined by NCI CTCAE v4.0 criteria.

To evaluate the efficacy of brigatinib as measured by investigator according to RECIST v1.1. TTR is defined as the time from the start of treatment to the first objective tumour response observed for patients who achieved Complete Response or Partial Response (according RECIST v.1.1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients	NCT04223596	Lung Cancer NSCLC NSCLC Stage III... NSCLC Stage IV	Brigatinib	18 Years -	Fundación GECP
Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients	NCT04223596	Lung Cancer NSCLC NSCLC Stage III... NSCLC Stage IV	Brigatinib	18 Years -	Fundación GECP

Spots Global Cancer Trial Database for metastasic sclc