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

NCT ID: NCT03042221

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-10
• Study Completion Date: 2027-09-30

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.

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 Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Schenk

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado, Cancer Center

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brandi Kubala

Role: CONTACT

brandi.kubala@cuanschutz.edu

303-724-1657

Facility Contacts

Brandi Kubala

Role: primary

brandi.kubala@cuanschutz.edu

303-724-1657

Erin Schenk

Role: backup

erin.schenk@cuanschutz.edu

303-724-4304

Other Identifiers

15-2316.cc

Identifier Type: -

Identifier Source: org_study_id