Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy

Launched by UNIVERSITY OF COLORADO, DENVER · Feb 1, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at how cancer cells in patients with advanced lung cancer respond to specific targeted treatments, called Tyrosine Kinase Inhibitors (TKIs). The goal is to identify early changes in the cancer cells that help them survive these treatments. By understanding these changes, researchers hope to find better ways to stop the cancer from resisting treatment and to improve patient outcomes.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) with a specific gene mutation that can be treated with targeted therapy. You should not have had any prior systemic treatments for this cancer. Participants will undergo tests, including biopsies or blood draws, to gather information before and after starting the treatment. It’s important to know that the study is currently recruiting participants, and you will need to sign a consent form to participate. This trial offers a chance to contribute to important research that could help future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Targetable Oncogene - Biopsy Cohort (includes blood draw)
• • 1. Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
• • 2. Aged 18 years or older
• • 3. ECOG 0-2
• • 4. Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
• • 5. No prior systemic therapy for locally advanced or metastatic disease.
• • 6. Planned treatment with targeted therapy specific to the oncogene driver mutation.
• • 7. Patients must have at least one site of measurable disease ≥ 2cm.
• • 8. Primary disease site or site of metastatic disease must be amenable to biopsy.
• • 9. Patients must have the ability to understand and willingness to sign an informed consent document.
• • Targetable Oncogene - Blood Draw Only Cohort
• • 1. Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)
• • 2. Aged 18 years or older
• • 3. ECOG 0-2
• • 4. Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
• • 5. No prior systemic therapy or radiotherapy for metastatic lung cancer (surgery alone permitted)
• • 6. Planned treatment with targeted therapy specific to the oncogene driver mutation.
• • 7. Declines repeat biopsy option or does not have tumor site amenable to biopsy.
• • 8. Patients must have the ability to understand and willingness to sign an informed consent document.
• • Immunotherapy Cohort - Blood Draw Only
• • 1. 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.
• • 2. Aged 18 years or older
• • 3. ECOG 0-2
• • 4. No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)
• • 5. Patients must have the ability to understand and willingness to sign an informed consent document.
• Exclusion Criteria:
• • Targetable Oncogene - Biopsy Cohort (includes blood draw)
• • 1. Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
• • 2. Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.
• • 3. Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .
• • Targetable Oncogene Cohort and Immunotherapy Cohort - Blood Draw Only
• • 1. Planned follow up on therapy outside of the University of Colorado Health System
• • 2. Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.