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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03535740
Registration number
NCT03535740
Ethics application status
Date submitted
9/05/2018
Date registered
24/05/2018
Date last updated
25/08/2023
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
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Scientific title
Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
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Secondary ID [1]
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2018-000635-27
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Secondary ID [2]
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Brigatinib-2002
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Universal Trial Number (UTN)
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Trial acronym
ALTA-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
ALK-positive Advanced NSCLC
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC)
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Assessment method [1]
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Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), per RECIST version 1.1 (confirmed =4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions taking as reference the Baseline sum diameters.
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Timepoint [1]
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Up to approximately 20 months from the start of enrollment till data cut-off 30 September 2020
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Secondary outcome [1]
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Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator
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Assessment method [1]
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Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved CR or PR, per RECIST version 1.1 (confirmed =4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters.
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Timepoint [1]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [2]
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Duration of Response (DOR) as Assessed by the Investigator and IRC
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Assessment method [2]
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DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that the progressive disease (PD) is objectively documented, or death. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the Baseline sum diameters. PD: SLD increased by at least 20% from the smallest value on study (including Baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify).
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Timepoint [2]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [3]
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Progression-Free Survival (PFS) as Assessed by the Investigator and IRC
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Assessment method [3]
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PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. PFS will be censored for participants without documented disease progression or death.
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Timepoint [3]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [4]
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Disease Control Rate (DCR) as Assessed by the Investigator and IRC
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Assessment method [4]
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DCR is defined as the percentage of participants who have achieved CR, PR or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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Timepoint [4]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [5]
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Time to Response as Assessed by the Investigator and IRC
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Assessment method [5]
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Time to response is defined as the time interval from the date of the first dose of the study treatment until the initial observation of CR or PR. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters.
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Timepoint [5]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [6]
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Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
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Assessment method [6]
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Confirmed iORR is defined as the proportion of the participants who have achieved CR or PR in the brain per a modification of RECIST version 1.1, after the initiation of study treatment, in participants with intracranial brain metastases at baseline. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. or partial response or PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters.
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Timepoint [6]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [7]
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Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC
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Assessment method [7]
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Duration of intracranial response is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that PD (including baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm. (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify) in the brain is objectively documented or death, in participants with intracranial metastases at baseline. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. or partial response or PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters in the brain. PD: SLD increased by at least 20% from the smallest value on study.
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Timepoint [7]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [8]
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Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
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Assessment method [8]
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iPFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which intracranial brain disease progression is objectively documented, or death due to any cause, whichever occurs first, in participants with intracranial metastases at enrollment. iPFS will be censored for participants without documented intracranial disease progression or death.
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Timepoint [8]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [9]
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Overall Survival (OS)
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Assessment method [9]
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OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. It will be censored on the date of last contact for those participants who are alive.
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Timepoint [9]
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Until the radiological disease progression or study end (approximately 3 years)
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Secondary outcome [10]
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Number of Participants With One or More Treatment-emergent Adverse Event (TEAE)
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Assessment method [10]
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An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.
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Timepoint [10]
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First dose of study drug up to 30 days after last dose (approximately 3 years)
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Secondary outcome [11]
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Health-Related Quality of Life (HRQOL) From European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
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Assessment method [11]
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EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.
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Timepoint [11]
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First dose of study drug up to 30 days after last dose (approximately 3 years)
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Secondary outcome [12]
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HRQOL From EORTC QLQ- Lung Cancer (LC) 13
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Assessment method [12]
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HRQOL scores will be assessed with EORTC, its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
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Timepoint [12]
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First dose of study drug up to 30 days after last dose (approximately 3 years)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Saint Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [2]
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Peninsula & South Eastern Haematology and Oncology Group - Frankston
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Recruitment hospital [3]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Virginia
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Austria
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Carinthia
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Austria
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Upper Austria
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Guangdong
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China
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Jilin
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China
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Shanghai
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China
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Zhejiang
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France
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Aquitaine
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France
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Ile-de-france
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France
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Midi-pyrenees
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France
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Provence Alpes COTE D'azur
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France
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Rhone-alpes
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Germany
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Baden-wuerttemberg
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Germany
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Bavaria
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-westfalen
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Germany
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Berlin
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Hong Kong
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New Territories
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Italy
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Lazio
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Italy
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Pordenone
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Italy
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Torino
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Italy
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Milano
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Italy
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Napoli
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Italy
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Parma
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Italy
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Ravenna
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Japan
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Aichi
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangbuk-do
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Korea, Republic of
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Daegu
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Seoul
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Netherlands
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Limburg
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Netherlands
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Noord-holland
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Netherlands
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Zuid-holland
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Spain
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Barcelona
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Spain
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LA Coruna
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Spain
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Madrid
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Sweden
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Skane
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Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Changhwa
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Taiwan
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Tainan CITY
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Taiwan
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State/province [63]
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Taichung
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ariad Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Takeda
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study is to determine the efficacy of brigatinib by confirmed
objective response rate (ORR) by response evaluation criteria in solid tumors (Response
Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or
metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03535740
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03535740
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