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

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ClinicalTrials.gov Identifier: NCT04151940
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This trial studies 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.

Condition or disease Intervention/treatment
Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Procedure: Positron Emission Tomography Procedure: Computed Tomography Drug: Chemotherapy Biological: Immunotherapy Radiation: 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Group/Cohort Intervention/treatment
Observational (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.
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
  • Medical Imaging
  • PET
  • PET scan
  • positron emission tomography scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
  • CAT
  • CAT Scan
  • computerized axial tomography
  • computerized tomography
  • CT
  • CT SCAN

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

Radiation: Radiation Therapy
Undergo standard of care radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • irradiated
  • Irradiation
  • Radiation
  • Radiotherapeutics
  • radiotherapy
  • RT




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: At 1 year ]
    Will be compared between high-risk and low-risk subgroups of patients based on PET imaging response assessment using a two-sample proportionality test. Interim and final statistical analyses of PFS will consist of Kaplan-Meier estimation and Cox proportional hazard regression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic non-small cell lung cancer (NSCLC) scheduled to receive chemo-immunotherapy per standard clinical care
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151940


Contacts
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Contact: Rafael Santana-Davila 206.606.2190 rsantana@seattlecca.org
Contact: Stephen Bowen 206.543.6559 srbowen@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Sub-Investigator: Stephen R. Bowen, PhD         
Sub-Investigator: Jing Zeng, MD         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rafael Santana-Davila Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT04151940     History of Changes
Other Study ID Numbers: RG1005458
NCI-2019-07068 ( Registry Identifier: NCI / CTRP )
10203 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Washington:
Lung
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases