Response of Bone Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers with Actionable Driver Mutations

Status: Active

Description

This trial studies the response of bone metastasis to tyrosine kinase inhibitors in non-small cell lung cancers with actionable driver mutations. This study plans to learn more about how different drug regimens for advanced non-small cell lung cancer and bone metastases affect bone turnover markers and the need for additional drugs to treat bone metastases.

Eligibility Criteria

Inclusion Criteria

  • Provision to sign and date the consent form
  • Stated willingness to comply with all study procedures and be available for the duration of the study
  • Pathologically confirmed non-small cell lung cancer with bone metastasis and elevated urine NTX level (i.e. >= 64 nmol bone collagen equivalents [BCE]/mmol creatinine at baseline) with or without driver actionable oncogene
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • Decision to be on a particular standard of care TKI or chemotherapy/immunotherapy (clinical decision that would occur prior to study enrollment)

Exclusion Criteria

  • Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
  • Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation of the drug study

Locations & Contacts

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: David Ross Camidge
Phone: 720-848-0483

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess percentage normalization of urine cross-linked N-telopeptide of type I collagen (NTX) in patient with non-small cell lung cancer (NSCLC) and bone metastases 1) with actionable driver oncogene on tyrosine kinase inhibitor (TKI) at 3 months post treatment and 2) without actionable mutations on standard of care (SOC) therapy (chemotherapy/immunotherapy) treated with zoledronic acid or denosumab at the same time period.

SECONDARY OBJECTIVES:

I. To assess percentage normalization of urine NTX in patients with NSCLC and bone metastases 1) with actionable driver oncogene on TKI at 1, 6, and 12 months post treatment and 2) without actionable mutations on SOC therapy (chemotherapy/immunotherapy) treated with zoledronic acid or denosumab at the same time periods as for 1.

II. To assess skeletal-related events (SREs) on therapy for both arms 1 and 2.

III. To estimate progression free survival (PFS) and overall response rate (ORR), as determined per the MD Anderson (MDA) criteria for patients who receive computed tomography (CT) or bone scans and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) for patients who undergo fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT as SOC.

IV. To assess percentage normalization of blood total alkaline phosphatase from baseline at 1, 3, 6, and 12 months post treatment tested as SOC.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I (WITH ACTIONABLE MUTATION): Patients receive a TKI as part of SOC. Patients also undergo collection of urine at baseline, 1, 3, 6, and 12 months.

ARM II (WITHOUT ACTIONABLE MUTATION): Patients receive chemotherapy or immunotherapy and zoledronic acid intravenously (IV) every 4 weeks or denosumab subcutaneously (SC) every 12 weeks for 12 months as part of SOC in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of urine at baseline, 1, 3, 6, and 12 months.

After completion of study, patients are followed up at 30 days.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Basic science

Lead Organization

Lead Organization
University of Colorado Hospital

Principal Investigator
David Ross Camidge

Trial IDs

Primary ID 19-0392
Secondary IDs NCI-2019-03377
Clinicaltrials.gov ID NCT03958565