Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Brigatinib for Non-Small Cell Lung Cancer (ALTA-2 Trial)
Phase 2
Waitlist Available
Research Sponsored by Ariad Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator
Documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test approved by the food and drug administration (FDA) or documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until the radiological disease progression or study end (approximately 3 years)
Awards & highlights
ALTA-2 Trial Summary
This trial will test the effectiveness of brigatinib on patients with ALK+ non-small cell lung cancer who have already tried and failed treatment with alectinib or ceritinib.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has worsened despite treatment with alectinib or ceritinib. Participants must have at least one measurable tumor, recovered from previous therapy side effects (except hair loss and certain nerve damage), and not received more than three systemic cancer treatments for advanced disease.Check my eligibility
What is being tested?
The study tests the effectiveness of brigatinib in treating ALK+ NSCLC after progression on alectinib or ceritinib. The main goal is to see how tumors respond to brigatinib using standard response criteria. Patients' tumors must be tested positive for ALK rearrangement.See study design
What are the potential side effects?
Brigatinib may cause side effects such as high blood pressure, vision changes, muscle pain, fatigue, nausea, diarrhea, coughing and potential risks to heart rhythm. Side effect experiences can vary among individuals.
ALTA-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one tumor that can be measured.
Select...
My cancer has a specific genetic change (ALK rearrangement) confirmed by a test.
Select...
My last treatment for cancer was with alectinib or ceritinib.
Select...
My lung cancer is at an advanced stage and cannot be cured with surgery.
Select...
My condition worsened while I was on alectinib or ceritinib.
ALTA-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until the radiological disease progression or study end (approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until the radiological disease progression or study end (approximately 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC)
Secondary outcome measures
Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator
Disease Control Rate (DCR) as Assessed by the Investigator and IRC
+9 moreSide effects data
From 2021 Phase 3 trial • 275 Patients • NCT0273750157%
Diarrhoea
50%
Blood Creatine Phosphokinase Increased
36%
Cough
32%
Hypertension
32%
Nausea
26%
Back Pain
26%
Aspartate Aminotransferase Increased
23%
Headache
23%
Dyspnoea
23%
Alanine Aminotransferase Increased
23%
Lipase Increased
22%
Vomiting
21%
Fatigue
21%
Pruritus
20%
Arthralgia
19%
Constipation
18%
Rash
17%
Dizziness
15%
Muscle Spasms
15%
Pyrexia
13%
Upper Respiratory Tract Infection
13%
Abdominal Pain
13%
Blood Alkaline Phosphatase Increased
13%
Asthenia
12%
Decreased Appetite
11%
Dyspepsia
11%
Musculoskeletal Pain
10%
Insomnia
10%
Dermatitis Acneiform
10%
Myalgia
10%
Oedema Peripheral
10%
Blood Cholesterol Increased
10%
Oropharyngeal Pain
9%
Productive Cough
9%
Nasopharyngitis
9%
Anaemia
9%
Paraesthesia
9%
Stomatitis
9%
Musculoskeletal Chest Pain
8%
Non-Cardiac Chest Pain
8%
Abdominal Pain Upper
7%
Urinary Tract Infection
7%
Bradycardia
7%
Epistaxis
7%
Pneumonia
7%
Pain In Extremity
7%
Rash Erythematous
6%
Dry Skin
6%
Rash Maculo-Papular
6%
Dysphonia
6%
Electrocardiogram Qt Prolonged
6%
Dry Mouth
6%
Eczema
6%
Blood Creatinine Increased
5%
Sinus Bradycardia
5%
Respiratory Tract Infection
5%
Hyperglycaemia
5%
Hypokalaemia
5%
Hypercholesterolaemia
5%
Vision Blurred
5%
Blood Lactate Dehydrogenase Increased
5%
Hypophosphataemia
5%
Rhinorrhoea
5%
Malaise
4%
Depression
4%
Dysgeusia
4%
Influenza Like Illness
4%
Peripheral Swelling
4%
Gamma-Glutamyltransferase Increased
4%
Neoplasm Progression
2%
Neutrophil Count Decreased
2%
Pulmonary Embolism
2%
Pleural Effusion
2%
Interstitial Lung Disease
2%
Hypocalcaemia
2%
Hypoaesthesia
2%
Taste Disorder
2%
Hypotension
1%
Toxicity To Various Agents
1%
Appendicitis
1%
Gastroenteritis
1%
Lower Respiratory Tract Infection
1%
Visual Impairment
1%
Disseminated Intravascular Coagulation
1%
Confusional State
1%
Cerebrovascular Accident
1%
Dysarthria
1%
Encephalopathy
1%
Peripheral Sensory Neuropathy
1%
Cholestasis
1%
Muscular Weakness
1%
Malignant Pleural Effusion
1%
Cancer Pain
1%
Diffuse Large B-Cell Lymphoma
1%
Invasive Breast Carcinoma
1%
Lung Neoplasm Malignant
1%
Ovarian Cancer Stage I
1%
Neutropenia
1%
Gout
1%
Syncope
1%
Seizure
1%
Memory Impairment
1%
Vocal Cord Paralysis
1%
Pericardial Effusion
1%
Cardiac Tamponade
1%
Acute Myocardial Infarction
1%
Angina Pectoris
1%
Arrhythmia
1%
Pneumonitis
1%
Pneumonia Aspiration
1%
Pneumothorax
1%
Pulmonary Oedema
1%
Dysphagia
1%
Inguinal Hernia
1%
Neutropenic Colitis
1%
Oesophageal Obstruction
1%
Cholecystitis
1%
Bile Duct Stone
1%
Multiple Organ Dysfunction Syndrome
1%
Sudden Death
1%
C-Reactive Protein Increased
1%
Transaminases Abnormal
1%
Femoral Neck Fracture
1%
Fall
1%
Ligament Rupture
1%
Hypoalbuminaemia
1%
Viral Infection
1%
Metastases To Meninges
1%
Lung Adenocarcinoma
1%
Squamous Cell Carcinoma Of Skin
1%
Hypoglycaemia
1%
Delirium
1%
Balance Disorder
1%
Partial Seizures
1%
Atrial Fibrillation
1%
Hepatocellular Injury
1%
Acute Kidney Injury
1%
Photopsia
1%
Metastases To Central Nervous System
1%
Hyperkalaemia
1%
Cognitive Disorder
1%
Gastric Haemorrhage
1%
Mucosal Inflammation
1%
Gastrooesophageal Reflux Disease
1%
Respiratory Distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Phase: Brigatinib 90 mg QD/180 QD
Randomized Phase: Crizotinib 250 mg BID
Crossover Phase: Brigatinib 90 mg QD/180 mg QD
ALTA-2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Brigatinib 90 mg/180 mg with Optional Dose Escalation to 240 mgExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Brigatinib
2018
Completed Phase 3
~890
Find a Location
Who is running the clinical trial?
Ariad PharmaceuticalsLead Sponsor
36 Previous Clinical Trials
3,786 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,159 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,063,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one tumor that can be measured.I have recovered from previous cancer treatment side effects, except for hair loss or nerve issues.I have been treated with both alectinib and ceritinib.My last treatment for cancer was with alectinib or ceritinib.My cancer has a specific genetic change (ALK rearrangement) confirmed by a test.I have taken an ALK inhibitor for cancer, but not crizotinib, alectinib, or ceritinib.I have brain metastasis but no new symptoms or increased need for steroids in the past week.I do not have any stomach or bowel problems that affect how I absorb pills.I have spinal cord compression or leptomeningeal disease without cord compression.I have not had a stroke or mini-stroke in the last 6 months.I was treated with an ALK inhibitor for at least 12 weeks before my cancer progressed.I have had more than 3 cancer treatments for advanced or spread cancer.My lung cancer is at an advanced stage and cannot be cured with surgery.My condition worsened while I was on alectinib or ceritinib.I do not have any current infections requiring IV antibiotics.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Brigatinib 90 mg/180 mg with Optional Dose Escalation to 240 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Brigatinib for public consumption?
"Our analysts at Power rate Brigatinib's safety a 2, as there is preliminary evidence of its protection but no proof yet that it works."
Answered by AI
What past experiments have been conducted utilizing Brigatinib?
"Brigatinib was first tested in a clinical setting at M D Anderson Cancer Center in 2018, and 6 trials have been concluded. Presently, 11 more studies are recruiting participants with several of these located in Calgary, British Columbia."
Answered by AI
How many venues are hosting this clinical experiment?
"The trial is ongoing in 14 medical centres, including those located in Calgary, Edmonton and Detroit. It would be prudent to select the clinic nearest you so as to limit travel requirements should you decide to take part."
Answered by AI
Is this trial actively admitting participants?
"Per data hosted on clinicaltrials.gov, this trial is no longer accepting participants as of November 15th 2022. However, at present there are a total of 1371 other medical studies actively seeking enrolment."
Answered by AI
How many participants have enrolled in this clinical research?
"At the present moment, this trial is not recruiting. It was first posted in January 2019 and last updated November 2022. However, there are 1360 studies for alk-positive advanced nsclc that are currently accepting patients as well as 11 trials specifically involving brigatinib which have open positions available."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger