BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases
Condition: Non Small Cell Lung Cancer With Bone Metastatses
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
Intervention: Xofigo
Intervention description: This is a radio-isotope
Intervention MeSH terms: Radium Ra 223 dichloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NCSLC; lung cancer; non small cell lung cancer; bone metastases; maintenance

Summary:

      In this study patient's will receive the medicine Xofigo which is a radioactive drug that is
      FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously
      been tested to treat lung cancer that has spread to the bones. Your doctors are studying the
      effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Advanced non-small cell lung cancer with bone metastases.

          -  Stable or responding disease after completion of initial systemic chemotherapy as
             defined by RECIST criteria. Site to submit confirmation to BrUOG.

          -  At least 3 weeks must have elapsed since completion of last chemotherapy and 4 weeks
             since last radiation, prior to first dose of Xofigo. Patients are not permitted to
             receive any form of 'maintenance' chemotherapy or biologic/targeted anticancer therapy
             while being treated on this study

          -  Life expectancy of at least 12 weeks (3 months).

          -  Patients with treated brain metastases are allowed, but must have brain imaging
             showing evidence of stability since most recent treatment for brain mets, prior to
             first dose of Xofigo. For patients with brain metastases only, brain imaging is
             required. Patients who do not have brain metastases or symptoms of potential brain
             metastases are not required to have baseline brain imaging, but this must be confirmed
             in writing

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.

          -  Required entry laboratory parameters within 14 days of study entry: White Blood Cell
             Count (WBC) ≥ 3,000/mm3; Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet (PLT)
             count ≥ 100,000/mm3; Hemoglobin (Hgb) > 9g/dl, Total bilirubin level ≤ 1.5 x
             institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) and
             alanine aminotransferase (ALT) ≤ 2.5 x ULN ; Creatinine ≤ 1.5 x ULN; Albumin > 2.5
             g/dL.

          -  Concurrent treatment with bisphosphonates and denosumab is allowed. Information on
             start and stop date and drug with dose to be sent to BrUOG if patient to be treated
             concurrently.

          -  Prior skeletal related events (pathologic fracture, radiation or surgery to bone, or
             spinal cord compression) are allowed if they have been managed and now patient is
             stable for 4 weeks prior to study entry. Must submit how events managed to BrUOG for
             documentation to confirm eligibility criterion. (For example, if a patient experienced
             a SSE and had radiation for 2 weeks they must then be stable for 4 weeks after the
             completion of radiation prior to study entry)

          -  Subjects must be able to understand and be willing to sign the written informed
             consent form.

          -  All acute toxic effects related to prior treatment(s) must have resolved to NCI-CTCAE
             v4 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for
             alopecia.

          -  Women of childbearing potential must have a negative serum pregnancy test performed
             within 7 days prior to the start of study drug. Post-menopausal women (defined as no
             menses for at least 1 year) and surgically sterilized women are not required to
             undergo a pregnancy test.

          -  Subjects (men and women) of childbearing potential must agree to use adequate
             contraception beginning at the signing of the ICF until at least 30 days after the
             last dose of study drug. The definition of adequate contraception will be based on the
             judgment of the treating physician.

          -  Willing and able to comply with the protocol, including follow-up visits and
             examinations

        Exclusion Criteria:

          -  Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153,
             rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony
             metastases

          -  No prior invasive malignancy within the prior two years. However, patients with an
             early stage malignancy that is not expected to require treatment in the next 2 years
             (such as early stage, resected breast cancer or asymptomatic prostate cancer) are
             eligible

          -  Untreated brain metastases.

          -  Any other serious illness or medical condition that in the investigator's opinion
             would interfere with protocol treatment, such as but not limited to: Any active
             infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events
             (NCI-CTCAE) version 4 Grade 2: Cardiac failure New York Heart Association (NYHA) III
             or IV

          -  Women who are pregnant or breast-feeding.

          -  Inability to comply with the protocol and/or not willing or who will not be available
             for follow-up assessments.

          -  Any condition which, in the investigator's opinion, makes the subject unsuitable for
             trial participation.

          -  Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery,
             immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride.

          -  Major surgery within 28 days of starting study drug. Central venous catheter placement
             is not considered major surgery.