Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 30, 2019
First Posted Date November 5, 2019
Last Update Posted Date November 5, 2019
Actual Study Start Date September 26, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer
Official Title An Observational Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • 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
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Procedure: Positron Emission Tomography
  • Procedure: Computed Tomography
  • Drug: Chemotherapy
  • Biological: Immunotherapy
  • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
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
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rafael Santana-Davila 206.606.2190 rsantana@seattlecca.org
Contact: Stephen Bowen 206.543.6559 srbowen@uw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04151940
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Washington
Study Sponsor University of Washington
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Rafael Santana-Davila Fred Hutch/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date November 2019