Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (CUBIK)
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|ClinicalTrials.gov Identifier: NCT04223596|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2020
Last Update Posted : June 2, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer NSCLC NSCLC Stage IIIB NSCLC Stage IV||Drug: Brigatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, non-randomised, phase II, exploratory, multi-country and multi-centre clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 4, 2020|
|Estimated Primary Completion Date :||April 15, 2024|
|Estimated Study Completion Date :||April 15, 2025|
Experimental: Experimental: Brigatinib Arm
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)
Other Name: AP26113
- Overall response rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of death, whichever came first, assessed up to 60 months ]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.
- Duration of response (DOR) [ Time Frame: From date of documentation of tumor response until date of first documented progression, assessed up to 60 months. ]To evaluate the efficacy of brigatinib as measured by investigator. Assessed as duration of response (DOR) according to RECIST v1.1
- Intracranial overall response rate (ORR) [ Time Frame: From date of documentation of tumor response until date of first documented progression, assessed up to 60 months. ]To evaluate the intracranial ORR defined as the proportion of patients with reduction in intracranial tumor
- Progression free survival (PFS) rate [ Time Frame: 1 year and 2 years of treatment with Brigatinib ]To evaluate PFS rate until first progression documented during the treatment with brigatinib by RECIST v1.1
- Overall Survival (OS) rate [ Time Frame: 1 year and 2 years of treatment with Brigatinib ]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.
- Safety and tolerability: NCI CTCAE v4.0 criteria [ Time Frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug. ]Occurrence and severity of adverse events, with severity determined by NCI CTCAE v4.0 criteria.
- Time on treatment (TTR) [ Time Frame: From date of the start of treatment until first objective tumour response observed (partial or complete according RECIST v1.1), assessed up to 60 months. ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223596
|Hospital Regional Universitario de Málaga|
|Málaga, Andalucia, Spain, 29010|
|Badalona, Barcelona, Spain, 08916|
|Hospitalet de Llobregat, Barcelona, Spain, 08908|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Cataluña, Spain, 08041|
|Hospital Universitario Insular de Gran canaria|
|Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016|
|Hospital Son Espases|
|Palma De Mallorca, Illes Balears, Spain, 07120|
|Hospital Universitario de Cruces|
|Baracaldo, Vizcaya, Spain, 48903|
|Complejo Hospitalario de A Coruña|
|A Coruña, Spain, 15006|
|Hospital General de Alicante|
|Alicante, Spain, 03010|
|Hospital Vall Hebron|
|Barcelona, Spain, 08035|
|Hospital Universitario Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Hospital Puerta de Hierro|
|Madrid, Spain, 28222|
|Hospital Clínico de Salamanca|
|Salamanca, Spain, 37007|
|Hospital Universitari i Politécnic La Fe|
|Valencia, Spain, 46009|
|Hospital General de Valencia|
|Valencia, Spain, 46014|
|Principal Investigator:||Mariano Provencio, MD||Fundación GECP President|