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Scientists peek inside lung tumors to outsmart drug resistance

NCT ID NCT03042221

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why some lung cancer cells survive targeted treatment. Researchers will take small tissue samples (biopsies) from 100 patients before and two weeks after starting therapy. By comparing the samples, they hope to find early signs of resistance and identify ways to block it, leading to better combination treatments in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2016

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects who have a diagnosis of State IV Lung Adenocarcinoma with EGFR activating mutation

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado, Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

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