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Tyrosine Kinase Inhibitor
Cabozantinib for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Alexander Drilon, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject has a Karnofsky performance status of > 70%
The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will help us understand if cabozantinib can help patients with gene RET, ROS1, or NTRK fusion or increased MET or AXL activity by inhibiting these genes that lead to lung cancer cell growth.
Who is the study for?
Adults with advanced non-small cell lung cancer that is metastatic or unresectable and have specific genetic changes (RET, ROS1, NTRK fusions, MET or AXL overexpression/amplification/mutation). Must be able to perform daily activities well (Karnofsky >70%), have good organ function, not pregnant, agree to use contraception. Excludes those with recent significant illnesses/treatments or known allergies to cabozantinib.Check my eligibility
What is being tested?
The trial tests the effects of an oral drug called Cabozantinib on patients with certain gene changes in their lung cancer cells. It's a phase II study which means it focuses on how effective this treatment is and monitors side effects closely.See study design
What are the potential side effects?
Cabozantinib may cause side effects like tiredness, digestive issues such as diarrhea and nausea, high blood pressure, hand-foot skin reactions, weight loss and decreased appetite. Some rare but serious side effects include bleeding or holes in the stomach/intestine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and engage in normal activities.
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I understand the study requirements and have signed the consent form.
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I am 18 years old or older.
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My cancer has specific genetic changes like KIF5B/RET, NTRK, MET, AXL, or ROS1.
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I am a woman who can have children and my pregnancy test was negative.
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I agree to use contraception if I'm sexually active.
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My lung cancer cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
objective response rate (ORR) (Group A)
objective response rate (ORR) (Group B)
Secondary outcome measures
overall survival (OS) (Group A)
overall survival (OS) (Group B, C & D)
progression-free survival (PFS) (Group A)
+2 moreOther outcome measures
objective response rate (ORR) (Group D)
Side effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
RASH
5%
Hoarseness
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Trial Design
1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
This will be a single-institution, open label, two-stage, single agent trial of cabozantinib in patients with advanced NSCLCs.atients in GROUP A will have tumors with a RET fusion. Patients in GROUP B will have tumors with an NTRK fusion, or MET or AXL overexpression, amplication, or mutatation. Patients in GROUP C will have tumors with a ROS1 fusion. Patients in GROUP D will have tumors with a RET fusion and have progressed on a selective RET TKI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,795 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,465 Total Patients Enrolled
Alexander Drilon, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study requirements and have signed the consent form.I have had serious bleeding or a tumor affecting major blood vessels in the last 28 days.Your disease can be measured using a specific set of guidelines called RECIST1.1.I have been treated with cabozantinib before.I haven't had radiation for bone or brain cancer, or any radiation treatment, in the last 2 to 4 weeks.I have recovered from previous treatment side effects, except for hair loss.I have untreated and symptomatic brain metastases.I am able to care for myself and engage in normal activities.I do not have any major health issues or surgeries that could interfere with the study.My blood tests meet the required health standards for organ and marrow function.I am 18 years old or older.My cancer has specific genetic changes like KIF5B/RET, NTRK, MET, AXL, or ROS1.I haven't taken any cancer drugs in the last 3 weeks or within 5 half-lives of the drug.I need to take blood thinners or medication to prevent blood clots.I am a woman who can have children and my pregnancy test was negative.I agree to use contraception if I'm sexually active.My lung cancer cannot be removed by surgery and has spread.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib
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 maladies has Cabozantinib been proven to be efficacious against?
"Cabozantinib is typically prescribed to those previously treated with anti-vegf medication, as well as for advanced renal cell carcinoma (ARCC), adrenal medulla malignancies, and individuals at high risk of developing cancer."
Answered by AI
What past initiatives have there been to investigate the potential of Cabozantinib?
"Initial trials of cabozantinib were carried out at Memorial Sloan Kettering Commack in 2012. Since then, 55 studies have been concluded and 109 are currently recruiting patients--many within the Basking Ridge region of New jersey."
Answered by AI
What objectives is this research endeavor aiming to achieve?
"The primary endpoints for this 12-week study are the objective response rate (ORR) in Group A. Secondary outcomes include progression-free survival (PFS) and overall survival (OS), both calculated using Kaplan-Meyer estimators, among Groups B, C & D with advanced NSCLCs whose tumors test positive for a ROS1 or NTRK fusion or MET or AXL overexpression or amplification who were treated with cabozantinib."
Answered by AI
How can Cabozantinib be utilized without risking adverse effects on patients?
"Due to the lack of efficacy data, Cabozantinib's safety is estimated at 2 on a scale from 1-3. However, there are some reports that support its safety profile."
Answered by AI
What is the current upper limit of participants in this investigation?
"Affirmative. The trial is recruiting participants, as indicated by the information provided on clinicaltrials.gov. It was first posted during July 1st 2012 and its details were last edited June 22nd 2022. 86 test subjects are to be recruited from seven different locations for this research effort."
Answered by AI
Is this the inaugural trial of its kind?
"Since its introduction in 2012, Exelixis has sponsored 55 Cabozantinib studies across 1315 cities and 45 countries. Of these trials, 109 are still live with the earliest reaching Phase 2 drug approval status with 86 participants 8 years ago."
Answered by AI
Are there vacancies for participation in this medical experiment?
"Indeed, clinicaltrials.gov verifies that this research effort is presently enrolling participants. Initially put up on July 1st 2012 and recently updated June 22nd 2022, the trial needs 86 individuals from 7 sites to be recruited."
Answered by AI
How many establishments in Canada are performing this experiment?
"The list of sites currently running this trial includes Memorial Sloan Kettering Basking Ridge in Basking Ridge, Memorial Sloan Kettering Nassau in Uniondale and Memorial Sloan Kettering Westchester in Harrison as well as 4 other medical centres."
Answered by AI
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