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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Recurrent Lung Non-Small Cell Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Drug: Chemotherapy; Biological: Immunotherapy

Detailed Description

Patients undergo PET/CT scan within 4 weeks before starting standard of care chemoimmunotherapy and a second PET/CT scan within 5 days of the second chemoimmunotherapy cycle. Patients receiving standard of care radiation treatment undergo additional PET/CT scans within 4 weeks prior to radiation treatment and 1 month post-radiation treatment. Additionally, patients undergo blood sample collection on study. Patients may also undergo magnetic resonance imaging (MRI) as clinically indicated throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen R. Bowen, PhD; Phone Number: 206-543-6559; Email: srbowen@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Stephen R. Bowen, PhD; Phone Number: 206-543-6559; Email: srbowen@uw.edu
      • Sub-Investigator: Stephen R. Bowen, PhD
      • Sub-Investigator: Jing Zeng, MD
      • Principal Investigator: Lei Deng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients with metastatic non-small cell lung cancer (NSCLC) scheduled to receive chemo-immunotherapy per standard clinical care

Description

Inclusion 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
• Subjects must be ≥ 18 years of age
• 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

Exclusion Criteria:

• 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)

  **Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Research (PET/CT scan); Patients undergo PET/CT scan within 4 weeks before starting standard of care chemoimmunotherapy and a second PET/CT scan within 5 days of the second chemoimmunotherapy cycle. Patients receiving standard of care radiation treatment undergo additional PET/CT scans within 4 weeks prior to radiation treatment and 1 month post-radiation treatment. Additionally, patients undergo blood sample collection on study. Patients may also undergo MRI as clinically indicated throughout the study.

Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; MRI Scan; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Procedure: Computed Tomography; Undergo PET/CT scan; Other Names: CT; CAT; CAT Scan; computerized tomography; CT SCAN; computerized axial tomography; Procedure: Positron Emission Tomography; Undergo PET/CT scan; Other Names: PET; Positron-Emission Tomography; PT; PET scan; Medical Imaging; positron emission tomography scan; Radiation: Radiation Therapy; Undergo standard of care radiation therapy; Other Names: Cancer Radiotherapy; Irradiate; Irradiation; Radiation; Radiotherapeutics; RT; radiotherapy; irradiated; Drug: Chemotherapy; Receive standard of care chemotherapy; Other Names: Chemo; Chemotherapy (NOS); Biological: Immunotherapy; Receive standard of care immunotherapy; Other Names: Immunological; Immunological Therapy; Immunologically Directed Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actuarial disease progression rate	Will be compared between high-risk and low-risk subgroups of patients based on positron emission tomography/computed tomography imaging biomarker changes using a two-sample proportionality test.	At 1 year

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lei Deng, MD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Lung
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Immunologic Factors; Physiological Effects of Drugs; Investigative Techniques; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Physical Phenomena; Chemistry Techniques, Analytical; Spectrum Analysis; Electromagnetic Phenomena; Magnetic Phenomena; Biological Therapy; Electromagnetic Radiation; Radiation, Ionizing; Immunomodulation; Radiotherapy; Radiation; Magnetic Resonance Spectroscopy; Drug Therapy; X-Rays; Immunotherapy; Adjuvants, Immunologic
• Other Study ID Numbers: RG1005458; NCI-2019-07068 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 10203 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R01CA258997 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes