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

BrUOG L301: Xofigo Following Frontline-Line Chemotherapy For Patients 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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer With Bone Metastatses
• Intervention / Treatment: Biological: Xofigo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital and The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xofigo; Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.	Biological: Xofigo; This is a radio-isotope; Other Names: Radium -223

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases	Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases	Approximately every 2 months for up to a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo	To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding	During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment
Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo	To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo	During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment

Collaborators and Investigators

• Sponsor: Angela Taber MD
• Collaborators: Bayer; The Miriam Hospital; Rhode Island Hospital
• Investigators: Study Chair: Howard Safran, MD, BrUOG Study Chair

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): November 13, 2018

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: lung cancer; bone metastases; maintenance; non small cell lung cancer; NCSLC
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: BrUOG 301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes