Identifying tumor survival mechanisms in lung cancer after targeted therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the characteristics of tumors in patients with oncogene-driven non-small cell lung cancer (NSCLC) before and after early treatment with Tyrosine Kinase Inhibitors (TKIs). By analyzing tumor biopsies and blood samples, researchers hope to identify early adaptive mechanisms that allow cancer cells to survive despite targeted therapy. This information could lead to the development of new treatment strategies that target these survival pathways, potentially improving patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Colorado, Cancer Center
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Erin Schenk — University of Colorado, Denver
• Study coordinator: Brandi Kubala
• Email: brandi.kubala@cuanschutz.edu
• Phone: 303-724-1657

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment options for advanced lung cancer with specific genetic mutations

  This study is testing different targeted treatments for people with advanced lung cancer that have specific genetic mutations to see which ones can help them live longer and feel better.

  Recruiting Phase 2 Hunan Province Tumor Hospital · Changsha, Hunan · NCT04322890

• Combining nitroglycerin with radiation therapy for lung cancer patients with brain metastases

  This study is testing if adding nitroglycerin to radiation therapy can help lung cancer patients with brain metastases live longer and feel better.

  Recruiting Instituto Nacional de Cancerologia de Mexico · Mexico City, Mexico City · NCT06238882

• Combining Nintedanib with EGFR inhibitors for advanced lung cancer

  This study is testing if combining a medication called Nintedanib with EGFR inhibitors can help people with advanced lung cancer who haven't responded to previous treatments.

  Recruiting Phase 1/2 China Medical University Hospital · Taichung · NCT06071013

• Evaluating BDTX-4933 for patients with specific cancer mutations

  This study is testing a new drug called BDTX-4933 to see if it can help adults with advanced cancers that have certain gene mutations feel better and improve their treatment options.

  Recruiting at 34 sites Phase 1/2 Servier · Gilbert, Arizona and 48 other locations · NCT05786924

• Combining Alectinib with Radiation Therapy for Advanced Lung Cancer with ALK Mutation

  This study is testing if combining alectinib with targeted radiation therapy can help people with advanced lung cancer that has an ALK mutation feel better and live longer.

  Recruiting Karolinska University Hospital · Stockholm · NCT05724004

• Evaluating Osimertinib with Early Stereotactic Radiosurgery for EGFR Mutated NSCLC with Brain Metastases

  This study is testing if combining a lung cancer drug called Osimertinib with early targeted radiation therapy can help people with EGFR-mutated non-small cell lung cancer and brain metastases live longer and maintain better brain function.

  Recruiting Hadassah Medical Organization · Jerusalem · NCT05033691

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.