Non-Small Cell Carcinoma of Lung, TNM Stage 4NCT03042221
Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy
An observational study of Non-Small Cell Carcinoma of Lung, TNM Stage 4 and Non-Small Cell Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-Small Cell Lung Cancer, EGFR Gene Mutation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have a diagnosis of State IV Lung Adenocarcinoma with EGFR activating mutation
Who may be able to join
- 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.
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- 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.
Who cannot join
- Targetable Oncogene - Biopsy Cohort (includes blood draw)
- Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
- 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.
- 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
- Planned follow up on therapy outside of the University of Colorado Health System
- Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado, Cancer Center
Aurora, Colorado, 80045
Brandi Kubala, 303-724-1657, brandi.kubala@cuanschutz.edu
Erin Schenk, 303-724-4304, erin.schenk@cuanschutz.edu
About this study
Official title: Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
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.
- Conditions
- Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROSE Cluster 1, BRAF V600E
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression changes
change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseq
Measured: baseline and 2 weeks (+/- 1 week) for each patient.
protein expression change
change from baseline of protein gene expression profile at 2 weeks as measured by multiplex protein assay (proteins to be assayed include: e-cadherin, vimentin, fibronectin, CD4, CD8, CD14, CD16, CD206, PDL1, and CSF1R)
Measured: baseline and 2 weeks (+/- 1 week) for each patient.
Secondary outcomes (1)
Depth of Response
Correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature.
Measured: Study startup through 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start10 May 2016
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Carcinoma of Lung, TNM Stage 4Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Schenk, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042221
- Sponsor's protocol ID
- 15-2316.cc
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2017
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
- ClinicalTrials.gov ID
- NCT03042221
- Acronym / sponsor ID
- 15-2316.cc
- Conditions
- Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROSE Cluster 1, BRAF V600E
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have a diagnosis of State IV Lung Adenocarcinoma with EGFR activating mutation
Key inclusion criteria (25 listed)
- 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)
Key exclusion criteria (7 listed)
- Targetable Oncogene - Biopsy Cohort (includes blood draw)
- Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gene expression changes
Time frame: baseline and 2 weeks (+/- 1 week) for each patient.
change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseq
protein expression change
Time frame: baseline and 2 weeks (+/- 1 week) for each patient.
change from baseline of protein gene expression profile at 2 weeks as measured by multiplex protein assay (proteins to be assayed include: e-cadherin, vimentin, fibronectin, CD4, CD8, CD14, CD16, CD206, PDL1, and CSF1R)
1 secondary outcome
Depth of Response
Time frame: Study startup through 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Schenk principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Carcinoma of Lung, TNM Stage 4 and Non-Small Cell Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandi Kubala (303-724-1657, brandi.kubala@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression changes (time frame: baseline and 2 weeks (+/- 1 week) for each patient.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.