NCT03042221 Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy
| NCT ID | NCT03042221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Non-Small Cell Carcinoma of Lung, TNM Stage 4 |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2016-05-10 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2016-05-10 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Erin Schenk
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT03042221 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Non-Small Cell Carcinoma of Lung, TNM Stage 4. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03042221 currently recruiting?
Yes, NCT03042221 is actively recruiting participants. Contact the research team at brandi.kubala@cuanschutz.edu for enrollment information.
Where is the NCT03042221 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT03042221 clinical trial?
NCT03042221 is sponsored by University of Colorado, Denver. The principal investigator is Erin Schenk at University of Colorado, Denver. The trial plans to enroll 100 participants.