RECRUITING

PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer

Conditions

Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Lung

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study investigates the changes in positron emission tomography (PET)/computed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET/CT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.

Official Title

An Interventional Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC

Quick Facts

Study Start:2019-09-26

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04151940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\] 8th edition for staging) * Evidence of stage IV disease on imaging by CT, PET/CT, or magnetic resonance imaging (MRI) * Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor * Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion * Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Creatinine =\< 2 mg/dL or creatinine clearance \> 50 mL/min * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5x institutional upper limit of normal * Total bilirubin =\< 1.5 mg/dL * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\>= 1500 per mm\^3) * Platelet count \>= 100 x 10\^9/L (\>=100,000 per mm\^3) * Capability to understand and comply with the protocol requirements and signed informed consent documents	* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment) * Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms * Has any serious or uncontrolled active infection that could create false positives on a PET/CT scan, in the opinion of the treating investigator * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs) * Has known, active, and symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis * Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day

Inclusion Criteria

Exclusion Criteria

* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\] 8th edition for staging)
* Evidence of stage IV disease on imaging by CT, PET/CT, or magnetic resonance imaging (MRI)
* Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor
* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion
* Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Creatinine =\< 2 mg/dL or creatinine clearance \> 50 mL/min
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5x institutional upper limit of normal
* Total bilirubin =\< 1.5 mg/dL
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\>= 1500 per mm\^3)
* Platelet count \>= 100 x 10\^9/L (\>=100,000 per mm\^3)
* Capability to understand and comply with the protocol requirements and signed informed consent documents

* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)
* Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
* Has any serious or uncontrolled active infection that could create false positives on a PET/CT scan, in the opinion of the treating investigator
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
* Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)
* Has known, active, and symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
* Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day

Contacts and Locations

Study Contact

Rafael Santana-Davila

CONTACT

206.606.2190

rsantan2@fredhutch.org

Stephen Bowen

CONTACT

206.543.6559

srbowen@uw.edu

Principal Investigator

Rafael Santana-Davila, MD

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: University of Washington

Rafael Santana-Davila, MD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-26

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2019-09-26

Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

Lung

Additional Relevant MeSH Terms

Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8