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

NCT ID: NCT04151940

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2027-11-30

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET/CT scan

Computed Tomography

Intervention Type: PROCEDURE

Undergo PET/CT scan

Chemotherapy

Intervention Type: DRUG

Receive standard of care chemotherapy

Immunotherapy

Intervention Type: BIOLOGICAL

Receive standard of care immunotherapy

Radiation Therapy

Intervention Type: RADIATION

Undergo standard of care radiation therapy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Interventions

Positron Emission Tomography

Undergo PET/CT scan

Intervention Type: PROCEDURE

Computed Tomography

Undergo PET/CT scan

Intervention Type: PROCEDURE

Chemotherapy

Receive standard of care chemotherapy

Intervention Type: DRUG

Immunotherapy

Receive standard of care immunotherapy

Intervention Type: BIOLOGICAL

Radiation Therapy

Undergo standard of care radiation therapy

Intervention Type: RADIATION

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Other Intervention Names

Medical Imaging; PET; PET scan; positron emission tomography scan; Positron-Emission Tomography; PT; CAT; CAT Scan; computerized axial tomography; computerized tomography; CT; CT SCAN; Chemo; Chemotherapy (NOS); Immunological; Immunological Therapy; Immunologically Directed Therapy; Cancer Radiotherapy; Irradiate; irradiated; Irradiation; Radiation; Radiotherapeutics; radiotherapy; RT; Biological Sample Collection; MRI; MRI Scan

Eligibility Criteria

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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Deng, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen R. Bowen, PhD

Role: CONTACT

srbowen@uw.edu

206-543-6559

Facility Contacts

Stephen R. Bowen, PhD

Role: primary

srbowen@uw.edu

206-543-6559

Other Identifiers

NCI-2019-07068

Identifier Type: REGISTRY

Identifier Source: secondary_id

10203

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA258997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1005458

Identifier Type: -

Identifier Source: org_study_id