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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
Must not have
Received both alectinib and ceritinib
Received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until the radiological disease progression or study end (approximately 3 years)
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured.
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My cancer has a specific genetic change (ALK rearrangement) confirmed by a test.
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My last treatment for cancer was with alectinib or ceritinib.
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My lung cancer is at an advanced stage and cannot be cured with surgery.
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My condition worsened while I was on alectinib or ceritinib.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with both alectinib and ceritinib.
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I have taken an ALK inhibitor for cancer, but not crizotinib, alectinib, or ceritinib.
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I do not have any stomach or bowel problems that affect how I absorb pills.
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I have had more than 3 cancer treatments for advanced or spread cancer.
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I do not have any current infections requiring IV antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until the radiological disease progression or study end (approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and until the radiological disease progression or study end (approximately 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC)
Secondary study objectives
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 more

Side effects data

From 2021 Phase 3 trial • 275 Patients • NCT02737501
57%
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%
Rash Maculo-Papular
6%
Dry Skin
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%
Lower Respiratory Tract Infection
1%
Appendicitis
1%
Gastroenteritis
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

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
1,227 Previous Clinical Trials
4,222,402 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorAriad Pharmaceuticals
197 Previous Clinical Trials
63,144 Total Patients Enrolled

Media Library

Brigatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03535740 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Brigatinib 90 mg/180 mg with Optional Dose Escalation to 240 mg
Non-Small Cell Lung Cancer Clinical Trial 2023: Brigatinib Highlights & Side Effects. Trial Name: NCT03535740 — Phase 2
Brigatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03535740 — Phase 2
~16 spots leftby Sep 2025
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