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Kinase Inhibitor

Brigatinib for Lung Cancer

Phase 1
Waitlist Available
Led By Collin Blakely, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment initiation through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, brigatinib and binimetinib, for patients with stage IIIB-IV non-small cell lung cancer and a rearrangement in the ALK or ROS1 genes.

Eligible Conditions
  • ROS1 Gene Rearrangement
  • Lung Cancer
  • ALK Gene Rearrangement
  • Non-Small Cell Lung Cancer
  • Progressive Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment initiation through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment initiation through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Grade 3 or Greater Treatment-Emergent Adverse Events by CTCAE v5.0
Number of Participants with Dose Limiting Toxicities
Number of Serious Treatment-Emergent Adverse Events by CTCAE v5.0
+6 more
Secondary outcome measures
Area Under the Plasma Concentration versus Time Curve (AUC) of Brigatinib
Median Depth of Response Assessed by RECIST v1.1
Median Overall Survival (OS)
+2 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%
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (brigatinib, binimetinib)Experimental Treatment2 Interventions
Patients receive brigatinib PO QD and binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brigatinib
2018
Completed Phase 3
~890
Binimetinib
2018
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,394 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,259 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,552 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer
2020. "Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04005144.
~1 spots leftby Apr 2025
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