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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
Must not have
The subject has experienced clinically-significant hematemesis or gastrointestinal bleeding, clinically-significant hemoptysis, radiographic evidence of cavitating pulmonary lesion(s), tumor in contact with invading major blood vessels, or evidence of an endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
Prior treatment with cabozantinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had serious bleeding or a tumor affecting major blood vessels in the last 28 days.
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I have been treated with cabozantinib before.
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I haven't had radiation for bone or brain cancer, or any radiation treatment, in the last 2 to 4 weeks.
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I have recovered from previous treatment side effects, except for hair loss.
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I have untreated and symptomatic brain metastases.
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I do not have any major health issues or surgeries that could interfere with the study.
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I haven't taken any cancer drugs in the last 3 weeks or within 5 half-lives of the drug.
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I need to take blood thinners or medication to prevent blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
objective response rate (ORR) (Group A)
objective response rate (ORR) (Group B)
Secondary study objectives
overall survival (OS) (Group A)
overall survival (OS) (Group B, C & D)
progression-free survival (PFS) (Group A)
+2 moreOther study objectives
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%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Hypotension
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
Allergic Rhinitis
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Behaviour Disturbance
5%
Scalp Pain
5%
Neuropathy
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
HEMATURIA
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Scalp Lesion
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2360
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,642 Total Patients Enrolled
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,084 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.
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