RecruitingPhase not listed

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

Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares tumor samples before targeted drug treatment and soon after it starts to learn how cancer cells survive. It is for adults with non-small cell lung cancer that has spread nearby or to distant parts of the body. Some groups give blood only, including a group starting treatment that helps the immune system fight 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All groups: Be age 18 or older and have non-small cell lung cancer confirmed by a tissue test that has spread nearby or is stage IV.
  • All groups: Be able to care for yourself and be out of bed or a chair for at least half the day (ECOG score 0–2).
  • All groups: Be able to understand the study and agree to sign a consent form.
  • Targeted treatment groups: Have a cancer gene change that can be treated with a targeted drug, and plan to start a drug matched to that change.
  • Biopsy group: Have had no whole-body drug treatment for cancer that has spread nearby or farther away. Have at least one tumor measuring 2 cm or more and a tumor site that can be sampled.
  • Targeted treatment, blood-only group: Have had no whole-body drug treatment or radiation for lung cancer that has spread to distant sites; surgery alone is allowed.
  • Targeted treatment, blood-only group: Decline a repeat biopsy (removing a small tissue sample), or have no tumor site that can be sampled.
  • Immune treatment, blood-only group: Have no gene change treatable with a targeted drug. Plan to start immune treatment, alone or with chemotherapy, as the first drug treatment. Have had no whole-body drug treatment or radiation for lung cancer; surgery alone is allowed.

Who can't join

  • Biopsy group: Have a health problem, such as a bleeding disorder, that prevents a biopsy.
  • Biopsy group: The only site available for a biopsy is too risky to sample, as judged by the doctor.
  • Biopsy group: The only sample available may not have enough genetic material for testing, as judged by the doctor.
  • Blood-only groups: Plan to have follow-up care during treatment outside the University of Colorado Health System.
  • Blood-only groups: Do not agree to let the study use leftover tissue from biopsies done for your care.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CO