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

NCT04151940 | Recruiting FDA Device

• 4 other identifiers: RG1005458NCI-2019-0706810203R01CA258997
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Lung

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Research (PET/CT scan)

EXPERIMENTAL

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: Positron Emission Tomography; Procedure: Computed Tomography; Drug: Chemotherapy; Biological: Immunotherapy; Radiation: Radiation Therapy; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging

Interventions

Positron Emission Tomography PROCEDURE

Undergo PET/CT scan

Also known as: Medical Imaging, PET, PET scan, positron emission tomography scan, Positron-Emission Tomography, PT

Research (PET/CT scan)

Computed Tomography PROCEDURE

Undergo PET/CT scan

Also known as: CAT, CAT Scan, computerized axial tomography, computerized tomography, CT, CT SCAN

Research (PET/CT scan)

Chemotherapy DRUG

Receive standard of care chemotherapy

Also known as: Chemo, Chemotherapy (NOS)

Research (PET/CT scan)

Immunotherapy BIOLOGICAL

Receive standard of care immunotherapy

Also known as: Immunological, Immunological Therapy, Immunologically Directed Therapy

Research (PET/CT scan)

Radiation Therapy RADIATION

Undergo standard of care radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, irradiated, Irradiation, Radiation, Radiotherapeutics, radiotherapy, RT

Research (PET/CT scan)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection

Research (PET/CT scan)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: MRI, MRI Scan

Research (PET/CT scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Magnetic Resonance Spectroscopy; X-Rays; Drug Therapy; Immunotherapy; Adjuvants, Immunologic; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation, Ionizing; Therapeutics; Immunomodulation; Biological Therapy; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Lei Deng, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen R. Bowen, PhD

CONTACT

206-543-6559; srbowen@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: September 26, 2019
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)