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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03535740




Registration number
NCT03535740
Ethics application status
Date submitted
9/05/2018
Date registered
24/05/2018

Titles & IDs
Public title
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
Scientific title
Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
Secondary ID [1] 0 0
2018-000635-27
Secondary ID [2] 0 0
Brigatinib-2002
Universal Trial Number (UTN)
Trial acronym
ALTA-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ALK-positive Advanced NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brigatinib

Experimental: Brigatinib 90 mg/180 mg with Optional Dose Escalation to 240 mg - Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 20 months until data cut-off: 30 September 2020. Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end.


Treatment: Drugs: Brigatinib
Brigatinib Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC)
Timepoint [1] 0 0
Up to approximately 20 months from the start of enrollment till data cut-off 30 September 2020
Secondary outcome [1] 0 0
Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator
Timepoint [1] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [2] 0 0
Duration of Response (DOR) as Assessed by the Investigator and IRC
Timepoint [2] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator and IRC
Timepoint [3] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [4] 0 0
Disease Control Rate (DCR) as Assessed by the Investigator and IRC
Timepoint [4] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [5] 0 0
Time to Response as Assessed by the Investigator and IRC
Timepoint [5] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [6] 0 0
Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Timepoint [6] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [7] 0 0
Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Timepoint [7] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [8] 0 0
Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Timepoint [8] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
Until the radiological disease progression or study end (approximately 3 years)
Secondary outcome [10] 0 0
Number of Participants With One or More Treatment-emergent Adverse Event (TEAE)
Timepoint [10] 0 0
First dose of study drug up to 30 days after last dose (approximately 3 years)
Secondary outcome [11] 0 0
Health-Related Quality of Life (HRQOL) From European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Timepoint [11] 0 0
First dose of study drug up to 30 days after last dose (approximately 3 years)
Secondary outcome [12] 0 0
HRQOL From EORTC QLQ- Lung Cancer (LC) 13
Timepoint [12] 0 0
First dose of study drug up to 30 days after last dose (approximately 3 years)

Eligibility
Key inclusion criteria
1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non-small-cell lung cancer (NSCLC).
2. Must meet both of the following 2 criteria:

1. Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.)
2. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
3. Had progressive disease (PD) while on alectinib or ceritinib
4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade <=1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade >1 are allowed if deemed irreversible.) and have adequate major organ functions.
7. Have a life expectancy of =3 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
2. Had received both alectinib and ceritinib.
3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled.
5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2024
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Carinthia
Country [11] 0 0
Austria
State/province [11] 0 0
Upper Austria
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Guangdong
Country [18] 0 0
China
State/province [18] 0 0
Jilin
Country [19] 0 0
China
State/province [19] 0 0
Shanghai
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
France
State/province [21] 0 0
Aquitaine
Country [22] 0 0
France
State/province [22] 0 0
Ile-de-france
Country [23] 0 0
France
State/province [23] 0 0
Midi-pyrenees
Country [24] 0 0
France
State/province [24] 0 0
Provence Alpes COTE D'azur
Country [25] 0 0
France
State/province [25] 0 0
Rhone-alpes
Country [26] 0 0
Germany
State/province [26] 0 0
Baden-wuerttemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Bavaria
Country [28] 0 0
Germany
State/province [28] 0 0
Bayern
Country [29] 0 0
Germany
State/province [29] 0 0
Niedersachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-westfalen
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Hong Kong
State/province [32] 0 0
New Territories
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Hong Kong
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Kowloon
Country [35] 0 0
Italy
State/province [35] 0 0
Lazio
Country [36] 0 0
Italy
State/province [36] 0 0
Pordenone
Country [37] 0 0
Italy
State/province [37] 0 0
Torino
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Italy
State/province [40] 0 0
Parma
Country [41] 0 0
Italy
State/province [41] 0 0
Ravenna
Country [42] 0 0
Japan
State/province [42] 0 0
Aichi
Country [43] 0 0
Japan
State/province [43] 0 0
Kanagawa
Country [44] 0 0
Japan
State/province [44] 0 0
Miyagi
Country [45] 0 0
Japan
State/province [45] 0 0
Okayama
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka
Country [47] 0 0
Japan
State/province [47] 0 0
Tokyo
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Gyeonggi-do
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Gyeongsangbuk-do
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Daegu
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Netherlands
State/province [52] 0 0
Limburg
Country [53] 0 0
Netherlands
State/province [53] 0 0
Noord-holland
Country [54] 0 0
Netherlands
State/province [54] 0 0
Zuid-holland
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
LA Coruna
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Sweden
State/province [58] 0 0
Skane
Country [59] 0 0
Sweden
State/province [59] 0 0
Stockholm
Country [60] 0 0
Sweden
State/province [60] 0 0
Uppsala
Country [61] 0 0
Taiwan
State/province [61] 0 0
Changhwa
Country [62] 0 0
Taiwan
State/province [62] 0 0
Tainan CITY
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ariad Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03535740