RECRUITING

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

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Conditions

Carcinoma, Non-Small-Cell Lung

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess percentage reduction in the of urine NTX and serum CTX , in patients with NSCLC and bone metastases 1) with actionable driver oncogene on standard of care (SOC) TKI at 3 months post treatment and 2) without actionable mutations on standard of care therapy (chemotherapy/immunotherapy) treated with zoledronic acid or denosumab at the same time period.

Official Title

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

Quick Facts

Study Start:2020-04-28
Study Completion:2026-03-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03958565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision to sign and date the consent form
  2. 2. Stated willingness to comply with all study procedures and be available for the duration of the study
  3. 3. Be a male or female aged 18-100 years
  4. 4. Pathologically confirmed non-small cell lung cancer
  5. 5. Molecular testing through a CLIA-validated NGS assay. This can be done using either tissue based samples or blood-based samples (ctDNA)
  6. 6. ECOG PS 0-2
  7. 7. Decision to be on a particular standard of care TKI or chemotherapy +/- immunotherapy (clinical decision that would occur prior to study enrollment)
  8. 8. Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment
  9. 9. Bone metastases must be detected through radiographic imaging prior to enrollment on this study.
  1. 1. Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
  2. 2. Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation while on standard of care treatments for the NSCLC.
  3. 3. Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening
  4. 4. Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy

Contacts and Locations

Study Contact

Vincent Johnson
CONTACT
13037249805
vincent.p.johnson@cuanschutz.edu

Principal Investigator

Tejas Patil, MD
PRINCIPAL_INVESTIGATOR
Colorado Research Center

Study Locations (Sites)

University of Colorado Hospital
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Tejas Patil, MD, PRINCIPAL_INVESTIGATOR, Colorado Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-28
Study Completion Date2026-03-05

Study Record Updates

Study Start Date2020-04-28
Study Completion Date2026-03-05

Terms related to this study

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung