Recruiting PHASE2 Non-Small Cell Lung Cancer

New treatment option for Non-Small Cell Lung Cancer

Official title Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity

ClinicalTrials.gov ID: NCT01639508

What this study is testing

What is Cabozantinib?

Cabozantinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity. A phase II study looks at how effective a medication is at treating a specific type of cancer and collects information on the side effects of the study treatment.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • A subject must fully meet all of the following criteria to be eligible for the study:
  • The subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectable.
  • Documented presence:
  • Group A: KIF5B/RET or related variant RET fusions.
  • Group B: any of the following aberrations ii. NTRK fusion iii. MET overexpression, amplification, or mutation iv. AXL overexpression, amplification...

You likely can't join if

  • Any type of systemic anticancer agent (including investigational) within 3 weeks of first dose of study treatment, or within 5 half-lives of the...
  • Prior treatment with cabozantinib
  • Radiation therapy for bone or brain metastasis within 2 weeks, any other external radiation therapy within 4 weeks of first dose of study drug...
  • The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically...
  • Known uncontrolled symptomatic brain metastases or cranial epidural disease; people previously treated and on stable dose of corticosteroids and/or...
  • The subject requires concomitant treatment, in therapeutic doses, unless deemed clinically unsafe to discontinue, with anticoagulants such as...
See the full eligibility criteria
Who can join
  • A subject must fully meet all of the following criteria to be eligible for the study:
  • The subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectable.
  • Documented presence:
  • Group A: KIF5B/RET or related variant RET fusions.
  • Group B: any of the following aberrations ii. NTRK fusion iii. MET overexpression, amplification, or mutation iv. AXL overexpression, amplification, or mutation
  • Group C: ROS1 fusion
  • GROUP D: RET-fusion post-progression on selective RET inhibitor
  • The subject is ≥ 18 years old on the day of consent.
  • Measurable Disease by RECIST1.1
  • The subject has a Karnofsky performance status of \> 70%.
  • The subject has organ and marrow function and laboratory values as follows:
  • Absolute neutrophil count (ANC) ≥ 1500/mm3 without colony stimulating factor support
  • Platelets ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 × the upper limit of normal (ULN). For people with known Gilbert's . disease, bilirubin ≤ 3.0 mg/dL
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 30 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum...
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN if no liver involvement, or ≤ 5 × ULN with liver involvement
  • Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (113.2 mg/mmol) creatinine or 24-hr urine protein of \< 1 g
  • Serum phosphorus, magnesium, and potassium ≥ LLN after adequate supplementation if necessary
  • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document. Sexually active people (men and women) must agree to use medically accepted barrier...
  • Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not...
  • Postmenopause is defined as amenorrhea ≥ 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior...
What rules you out
  • Any type of systemic anticancer agent (including investigational) within 3 weeks of first dose of study treatment, or within 5 half-lives of the agent whichever is shorter. people on LHRH or GnRH agonists may be...
  • Prior treatment with cabozantinib
  • Radiation therapy for bone or brain metastasis within 2 weeks, any other external radiation therapy within 4 weeks of first dose of study drug. Systemic treatment with radionuclides within 4weeks. people with clinically...
  • The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.
  • Known uncontrolled symptomatic brain metastases or cranial epidural disease; people previously treated and on stable dose of corticosteroids and/or anticonvulsants for \>10 days, or not requiring such medications, are...
  • The subject requires concomitant treatment, in therapeutic doses, unless deemed clinically unsafe to discontinue, with anticoagulants such as warfarin or warfarin-related agents, unfractionated heparin, thrombin or...
  • The subject has experienced any of the following within 3 months before the first dose of study treatment:
  • clinically-significant hematemesis or gastrointestinal bleeding
  • Clinically-significant hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood c. any other signs indicative of pulmonary hemorrhage
  • The subject has radiographic evidence of cavitating pulmonary lesion(s)
  • The subject has tumor in contact with invading major blood vessels
  • The subject has any evidence of an endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib.
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders including Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
  • Concurrent uncontrolled hypertension defined as sustained BP ≥ 150 mm Hg systolic, or ≥ 90 mm Hg diastolic despite optimal antihypertensive treatment (Note: If there is any BP measurement that is performed within the...
  • Any of the following within 6 months before the first dose of study treatment:
  • unstable angina pectoris
  • clinically-significant cardiac arrhythmias
  • stroke (including TIA, or other ischemic event) myocardial infarction
  • thromboembolic event requiring therapeutic anticoagulation except if anticoagulation is as stipulated in Exclusion Criterium #6. (Note: people with a venous filter (e.g. vena cava filter) are not eligible for this study)
  • Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
  • Any of the following within 28 days before the first dose of study treatmentF
  • intra-abdominal tumor/metastases invading GI mucosa (malignant abdominal ascites does not constitute mucosal invasion)
  • active peptic ulcer disease,
  • inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
  • malabsorption syndrome
  • Any of the following within 6 months before the first dose of study treatment:
  • history of abdominal fistula
  • gastrointestinal perforation
  • bowel obstruction or gastric outlet obstruction
  • intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 6 months ago. GI surgery...
  • Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy or concurrent evidence of intraluminal tumor involving the trachea and...
  • Other clinically significant disorders such as:
  • active infection requiring systemic treatment within 28 days before the first dose of study treatment
  • serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
  • history of organ transplant
  • concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
  • Major surgery (eg, thoracotomy, removal or biopsy of brain metastasis) within 3 months before Week 1 Day 1. Complete wound healing from major surgery must have occurred 1 month before Week 1 Day 1 and from minor surgery...
  • history of major surgery as follows:
  • The subject is unable to swallow tablets
  • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms 14 days before Week 1 Day 1
  • The subject is pregnant or breastfeeding.
  • The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  • Uncontrolled concurrent malignancy that would limit assessment of how well it works of cabozantinib.

The study team makes the final eligibility decision.

Where it's taking place

  • Basking Ridge, New Jersey, United States
  • Middletown, New Jersey, United States
  • Montvale, New Jersey, United States
  • Commack, New York, United States
  • Harrison, New York, United States
  • New York, New York, United States
  • Uniondale, New York, United States

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.