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Tyrosine Kinase Inhibitor
Brigatinib vs Alectinib for Non-Small Cell Lung Cancer (ALTA-3 Trial)
Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
ALTA-3 Trial Summary
This trial is for people with NSCLC whose cancer has returned or gotten worse after treatment with another medicine called crizotinib.
Who is the study for?
Adults with advanced non-small-cell lung cancer (NSCLC) who have good performance status, measurable tumors, and adequate organ function can join. They shouldn't have had certain recent treatments or uncontrolled illnesses like heart disease, infections, or brain metastases that cause symptoms.Check my eligibility
What is being tested?
The trial is testing whether brigatinib tablets are more effective than alectinib capsules in stopping tumor growth in NSCLC patients. Participants will be randomly assigned to one of the two drugs and take it daily until their condition worsens or they experience significant side effects.See study design
What are the potential side effects?
Possible side effects include reactions at the tablet/capsule intake site, fatigue, digestive issues such as nausea and diarrhea, blood disorders like anemia or clotting problems, liver enzyme changes indicating potential liver damage, and increased risk of infection.
ALTA-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at an advanced stage or has come back.
Select...
I am able to care for myself and perform daily activities.
ALTA-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1
Secondary outcome measures
Duration of Response (DOR) as Assessed by Investigator and BIRC
HRQOL from EORTC QLQ- Lung Cancer (LC) 13
Health-Related Quality of Life (HRQOL) from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score
+7 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-3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BrigatinibExperimental Treatment1 Intervention
Brigatinib 90 milligram (mg), tablets, orally, once daily 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
Group II: AlectinibActive Control1 Intervention
Alectinib 600 mg, capsules, orally twice daily until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
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?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,768 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
62,999 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious irregular heartbeats.I haven't taken experimental cancer drugs in the last 14 days or more.I have had severe heart failure in the last 6 months.My doctor has diagnosed me with a serious heart rhythm problem.I have had a stroke or mini-stroke in the last 6 months.I have a condition that affects how my body absorbs medication taken by mouth.I have spinal cord compression, detected by scans, with or without symptoms.I have no other cancers except for certain skin, cervical, or treated prostate cancers.I haven't had chemotherapy or radiation (except SRS or SBRT) in the last 14 days.You have been diagnosed with HIV in the past.You have at least one visible or measurable lesion according to specific guidelines.I have recovered from previous cancer treatment side effects, except for hair loss or nerve issues.Your kidney function, as measured by GFR, must be at least 30 mL/min/1.73 m2.Your blood test for lipase should be within a certain range.My brain metastases are stable, and I haven't needed more medication for symptoms in the last week.I do not have serious heart problems.I have had a heart attack in the last 6 months.I have not had unstable chest pain in the last 6 months.My lung cancer is at an advanced stage or has come back.I do not have a life-threatening illness unrelated to my cancer.I am able to care for myself and perform daily activities.I do not have any current infections requiring IV antibiotics.Your platelet count should be at least 75 billion per liter.Your body has enough infection-fighting white blood cells.I have or had lung inflammation due to disease, medication, or radiation.You were in a previous study where you received a medication called crizotinib as part of the control group.Your hemoglobin level is at least 9 grams per deciliter.I haven't taken strong or moderate drugs that affect liver enzymes in the last 2 weeks.My liver enzymes are within acceptable limits.My organs are functioning well.I have high blood pressure that is not well-controlled.I have received cancer treatment with monoclonal antibodies in the last 30 days.You have used illegal drugs, misused drugs, or abused alcohol.You have hepatitis B or active hepatitis C infection. Testing is not needed if you don't have a history of these infections.You are allergic to brigatinib or alectinib or any of the ingredients in these medications.I am currently breastfeeding.Your total bilirubin levels are not more than 1.5 times the upper limit of normal.I have not had major surgery in the last 30 days.I took crizotinib less than a week ago.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a lot of places in North America where people can participate in this trial?
"Right now, this trial is enrolling patients at 5 sites. They are situated in cities such as Halifax, Toronto and Athens. If you want to cut down on travel, it would be best to select the location nearest to you."
Answered by AI
Are we still enrolling patients in this experiment?
"Yes, this is an active trial that has been recruiting since 4/19/2019 according to the listing on clinicaltrials.gov. The posting was last updated on 4/1/2022."
Answered by AI
When did Brigatinib receive FDA approval?
"Brigatinib has received a score of 3 for safety. This is due to it being a Phase 3 trial, which contains data that supports the efficacy and safety of Brigatinib."
Answered by AI
Have there been similar studies to this one before?
"Brigatinib has been studied in 34 clinical trials across 591 cities and 59 countries. The first study occurred in 2014 and was sponsored by Genentech, Inc. That trial had 676 participants and completed Phase 2 drug approval stage. Since then, 17 additional studies have completed."
Answered by AI
What are the findings of similar research projects to Brigatinib?
"Brigatinib was originally studied in 2014 at Northwestern University. To date, a total of 34 clinical trials have been completed with 17 currently active. Out of these ongoing studies, many are being conducted in Halifax, Nova Scotia."
Answered by AI
How many individuals are being included in this experiment?
"In order to have statistically relevant data, 246 individuals who meet the eligibility standards set by the researchers need to participate. Currently, patients are able to enroll at sites like Queen Elizabeth II Health Sciences Centre in Halifax and Toronto University Health Network."
Answered by AI
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