Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms of cell survival. This will facilitate targeting and termination of these survival/ resistance pathways before they develop with rational combinations of therapeutic agents to improve outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ Targetable Oncogene - Biopsy Cohort (includes blood draw)

• Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)

• Aged 18 years or older

• ECOG 0-2

• Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)

• No prior systemic therapy for locally advanced or metastatic disease.

• Planned treatment with targeted therapy specific to the oncogene driver mutation.

• Patients must have at least one site of measurable disease ≥ 2cm.

• Primary disease site or site of metastatic disease must be amenable to biopsy.

• Patients must have the ability to understand and willingness to sign an informed consent document.

⁃ Targetable Oncogene - Blood Draw Only Cohort

• Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)

• Aged 18 years or older

• ECOG 0-2

• Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)

• No prior systemic therapy or radiotherapy for metastatic lung cancer (surgery alone permitted)

• Planned treatment with targeted therapy specific to the oncogene driver mutation.

• Declines repeat biopsy option or does not have tumor site amenable to biopsy.

• Patients must have the ability to understand and willingness to sign an informed consent document.

⁃ Immunotherapy Cohort - Blood Draw Only

• Have a histologically confirmed diagnosis of locally advanced or stage IV NSCLC without a treatable activating mutation that would be amenable to targeted therapy AND planned first line treatment with immunotherapy or chemotherapy plus immunotherapy.

• Aged 18 years or older

• ECOG 0-2

• No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)

• Patients must have the ability to understand and willingness to sign an informed consent document.

Locations
United States
Colorado
University of Colorado, Cancer Center
RECRUITING
Aurora
Contact Information
Primary
Brandi Kubala
brandi.kubala@cuanschutz.edu
303-724-1657
Time Frame
Start Date: 2016-05-10
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 100
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov