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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02737501




Registration number
NCT02737501
Ethics application status
Date submitted
30/03/2016
Date registered
14/04/2016

Titles & IDs
Public title
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
Scientific title
A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer
Secondary ID [1] 0 0
U1111-1210-4363
Secondary ID [2] 0 0
AP26113-13-301
Universal Trial Number (UTN)
Trial acronym
ALTA-1L
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Lung Cancer 0 0
Advanced Malignancies 0 0
Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

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

Experimental: Randomized Phase: Brigatinib 90 mg QD/180 QD - Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).

Active comparator: Randomized Phase: Crizotinib 250 mg BID - Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).

Experimental: Crossover Phase: Brigatinib 90 mg QD/180 mg QD - Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).


Treatment: Drugs: Brigatinib
Brigatinib tablets

Treatment: Drugs: Crizotinib
Crizotinib tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to end of study (Up to 56 months)
Secondary outcome [1] 0 0
Confirmed Objective Response Rate (ORR)
Timepoint [1] 0 0
Baseline up to end of treatment (Up to 36 months)
Secondary outcome [2] 0 0
Confirmed Intracranial ORR (iORR)
Timepoint [2] 0 0
Baseline up to end of treatment (Up to 36 months)
Secondary outcome [3] 0 0
Intracranial Progression Free Survival
Timepoint [3] 0 0
Baseline up to end of study (Up to 56 months)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Baseline up to end of study (Up to 56 months)
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Baseline up to end of study (Up to 56 months)
Secondary outcome [6] 0 0
Time to Response (TTR)
Timepoint [6] 0 0
Baseline up to end of treatment (Up to 36 months)
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
Baseline up to end of treatment (Up to 36 months)
Secondary outcome [8] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [8] 0 0
From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
Secondary outcome [9] 0 0
Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)
Timepoint [9] 0 0
Baseline and Month 36

Eligibility
Key inclusion criteria
1. Have histologically or cytologically confirmed stage IIIB (and not a candidate for definitive multimodality therapy) or stage four (IV) NSCLC.
2. Must have documented ALK rearrangement.
3. Have sufficient tumor tissue available for central analysis.
4. Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
5. Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (of the United States) (NCI) Common Terminology Criteria for Adverse Events (version 4.0) (CTCAE v 4.0) grade be less than or equal to (<=) 1.
6. Are a male or female participants greater than or equal to (>=)18 years old.
7. Have adequate organ function, as defined by the study protocol.
8. Have Eastern Cooperative Oncology Group (ECOG) performance status <=2.
9. Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of <= 450 millisecond (msec) in males or <=470 msec in females.
10. For female participants of childbearing potential, have a negative pregnancy test documented prior to randomization.
11. For female and male participants who are fertile, agree to use a highly effective form of contraception, as defined by the study protocol.
12. Provide signed and dated informed consent indicating that the participants has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
13. Have the willingness and ability to comply with scheduled visit and study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously received an investigational antineoplastic agent for NSCLC.
2. Previously received any prior tyrosine kinase inhibitor (TKI), including ALK-targeted TKIs.
3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
4. Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
5. Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
6. Had major surgery within 30 days of the first dose of study drug, minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
7. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
10. Be pregnant, planning a pregnancy, or breastfeeding.
11. Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol.
12. Have uncontrolled hypertension.
13. Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
14. Have an ongoing or active infection.
15. Have a known history of human immunodeficiency virus (HIV) infection.
16. Have a known or suspected hypersensitivity to brigatinib or its excipients and/or crizotinib or its excipients.
17. Have malabsorption syndrome or other gastrointestinal (GI) illness or condition.
18. Have any condition or illness that, in the opinion of the investigator, would compromise participant's safety or interfere with the evaluation of the study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
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
26/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2021
Sample size
Target
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Saint George Hospital - Kogarah
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Monash Medical Centre - Bentleigh East
Recruitment hospital [4] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Austria
State/province [12] 0 0
Lower Austria
Country [13] 0 0
Austria
State/province [13] 0 0
Vienna
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Denmark
State/province [15] 0 0
Odense C
Country [16] 0 0
France
State/province [16] 0 0
Basse-normandie
Country [17] 0 0
France
State/province [17] 0 0
Haute-normandie
Country [18] 0 0
France
State/province [18] 0 0
Ile-de-france
Country [19] 0 0
France
State/province [19] 0 0
Provence Alpes COTE D'azur
Country [20] 0 0
France
State/province [20] 0 0
Rhone-alpes
Country [21] 0 0
Germany
State/province [21] 0 0
Baden-wuerttemberg
Country [22] 0 0
Germany
State/province [22] 0 0
Niedersachsen
Country [23] 0 0
Germany
State/province [23] 0 0
Nordrhein-westfalen
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Hong Kong
State/province [26] 0 0
New Territories
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Hong Kong
Country [28] 0 0
Hong Kong
State/province [28] 0 0
Kowloon
Country [29] 0 0
Italy
State/province [29] 0 0
Forli-cesena
Country [30] 0 0
Italy
State/province [30] 0 0
Monza E Brianza
Country [31] 0 0
Italy
State/province [31] 0 0
Pordenone
Country [32] 0 0
Italy
State/province [32] 0 0
Avellino
Country [33] 0 0
Italy
State/province [33] 0 0
Bari
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Novara
Country [38] 0 0
Italy
State/province [38] 0 0
Perugia
Country [39] 0 0
Italy
State/province [39] 0 0
Ravenna
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Chungcheongbuk-do
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Gyeonggi-do
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Luxembourg
State/province [44] 0 0
Luxembourg
Country [45] 0 0
Netherlands
State/province [45] 0 0
Noord-brabant
Country [46] 0 0
Netherlands
State/province [46] 0 0
Noord-holland
Country [47] 0 0
Netherlands
State/province [47] 0 0
Overijssel
Country [48] 0 0
Netherlands
State/province [48] 0 0
Groningen
Country [49] 0 0
Norway
State/province [49] 0 0
Oslo
Country [50] 0 0
Singapore
State/province [50] 0 0
Singapore
Country [51] 0 0
Spain
State/province [51] 0 0
Asturias
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Alicante
Country [55] 0 0
Spain
State/province [55] 0 0
La Coruna
Country [56] 0 0
Spain
State/province [56] 0 0
Malaga
Country [57] 0 0
Spain
State/province [57] 0 0
Santander
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Sweden
State/province [60] 0 0
Stockholm
Country [61] 0 0
Switzerland
State/province [61] 0 0
Zurich
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taichung
Country [64] 0 0
United Kingdom
State/province [64] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ariad Pharmaceuticals
Address
Country

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/NCT02737501