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Monoclonal Antibodies
Brigatinib + Bevacizumab for Lung Cancer
Phase 1
Waitlist Available
Led By Victoria M. Villaflor, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have shown progression on ALK-directed therapy
Patients must have adequate organ and bone marrow function during screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing brigatinib with or without bevacizumab to treat patients with ALK-rearranged non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic) or has come back (recurrent).
Who is the study for?
This trial is for adults with ALK-rearranged non-small cell lung cancer that's advanced, spread elsewhere, or returned after treatment. They must have tried ALK-targeted therapy before and still show signs of the disease. Participants need to be in fairly good health overall, understand the study, agree to use contraception, and not have had certain treatments or surgeries recently.Check my eligibility
What is being tested?
Researchers are testing brigatinib combined with bevacizumab to see how well they work together against this type of lung cancer. Brigatinib targets enzymes needed by cancer cells to grow while bevacizumab aims to stop these cells from spreading.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding problems, fatigue, liver issues and risks related to heart health. There might also be reactions where the drugs are infused into the body and potential harm if a participant has surgery during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer progressed despite treatment targeting ALK.
Select...
My organs and bone marrow are functioning well.
Select...
I have brain metastases but no symptoms, and I don't have cancer in the lining of my brain.
Select...
My lung cancer is advanced, recurrent, or has spread and tests show ALK changes.
Select...
I am following the required birth control guidelines.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose
Secondary outcome measures
Dose-limiting toxicities
Duration of response
Overall response rate
+2 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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (brigatinib, bevacizumab)Experimental Treatment2 Interventions
Patients receive brigatinib PO QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles. Patients also receive bevacizumab IV on day 8 of cycle 1 and day 1 of subsequent cycles. Starting cycle 2, cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Brigatinib
2018
Completed Phase 3
~890
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,226 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,455 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,148 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 30 days.I have not had a recent pulmonary embolism or untreated deep vein thrombosis in the last 3 months.My cancer progressed despite treatment targeting ALK.I don't have any other cancers that are likely to worsen within a year.My organs and bone marrow are functioning well.I haven't had cancer treatment or radiation in the last 14 days.You had a bad reaction to bevacizumab in the past.You are expected to live for more than 12 weeks.I can understand and am willing to sign the study's consent form.I do not have uncontrolled heart problems.I do not have severe lung inflammation from drugs or radiation.You must have a detectable tumor according to specific guidelines.I have brain metastases but no symptoms, and I don't have cancer in the lining of my brain.My blood pressure is under control.I do not have severe unresolved lung disease.You are allergic to brigatinib or any of its ingredients.I haven't taken strong or moderate drugs that affect liver enzymes in the last 2 weeks.My lung cancer is advanced, recurrent, or has spread and tests show ALK changes.I haven't taken cancer drugs or TKIs in the last 3 weeks.I do not have a condition that affects how my body absorbs medication taken by mouth.I am a male and will follow the required contraception guidelines.I am following the required birth control guidelines.I do not have any uncontrolled illnesses.I have not had a stroke or mini-stroke in the last 6 months.I am not pregnant, planning to become pregnant, or nursing.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (brigatinib, bevacizumab)
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.
What aims are being sought through conducting this clinical experiment?
"The primary aim of this clinical trial, which will be assessed in the 30 days following treatment cessation or before commencement of next medication cycle, is to determine the maximum tolerated dosage. As for secondary objectives, Progression-free survival (PFS) shall be estimated using Kaplan-Meier method with a competing risk cumulative incidence used if multiple patients experience a change in treatment; Dose-limiting toxicities are evaluated during initial 28 day period among first 6-12 participants from safety cohort and Duration of response explored through medians and ranges analysis."
Answered by AI
What therapeutic applications is Brigatinib typically employed for?
"Brigatinib is traditionally employed as a means to treat recurrent platinum-sensitive epithelial ovarian cancer. It is also capable of managing malignant neoplasms, persistent cervical cancer, and the recurrence of cervical cancers."
Answered by AI
Are there any US-based healthcare settings in which this clinical trial is currently underway?
"At this time, 5 different medical facilities are participating in the trial. This includes City of Hope Medical Center (Aurora), University of Colorado Cancer Center (Madison) and University of Wisconsin Hospital and Clinics(Chicago). Two other clinics have yet to be announced."
Answered by AI
What potential risks are associated with Brigatinib?
"The safety of Brigatinib has been given a score of 1, as this is an early-phase trial and there are few data points supporting its efficacy or lack thereof."
Answered by AI
Could you please provide an estimate of the number of individuals involved in this research project?
"Affirmative. The information available on clinicaltrials.gov reveals that this research project is actively enrolling patients, having first appeared on March 9th 2020 and updated most recently on August 17th 2022. A total of 31 individuals will be recruited from 5 different medical centres."
Answered by AI
Has Brigatinib been subject to any past experiments or investigations?
"Currently, 365 clinical trials for Brigatinib are underway. Of those, 90 have reached Phase 3 and the majority of them originate in Taiwan's Taibei city. However, there are 17811 other locations running studies related to this medication."
Answered by AI
Are there any open slots available for the clinical trial at this time?
"Affirmative. According to clinicaltrials.gov, this research endeavour was launched on March 9th 2020 and is currently looking for participants. 31 individuals must be recruited from 5 different medical facilities."
Answered by AI
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