BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases

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.
Your doctors will also be evaluating changes in health related quality of life using the EORC
QL-C20 and QOL-BM22 questionnaires. They will also evaluate the impact of treatment on the
Alkaline phosphate levels (by way of lab draws) in patients and measure the progression free
survival and overall survival of patients with stable or responding disease after the front
line chemotherapy treated with Xofigo.

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.