Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine

Summary: The purpose of this study is to further advancements in biospecimens (blood cellular free component, e.g., plasma, serum, tissue), in order to develop precision medicine, for lung cancer management and lung cancer screening (synergy with imaging). A co-clinical trial approach, with integrative analyses leveraging data from the treatment of genetic mouse models of lung cancer along with clinical samples and data from lung cancer patients, will be used to elucidate genomic background metrics, identify cell free DNA mutations, and further refine the liquid biopsy approach.

Detailed description: This is a feasibility study to collect tumor and peripheral blood of patients with advanced NSCLC who receive treatment. Blood will also be collected from subjects without lung cancer to assess non cancer profiles. To conduct this study, a total of 30 study-eligible subjects of all races and ethnicities, aged 18 years or older with a diagnosis of Stage IV adenocarcinoma of the lung (Cohort A), will be enrolled and have their tumor collected once for molecular profiling and xenograft development and blood collected at prespecified time intervals until completion of treatment for liquid biopsy analysis (targeted sequencing, whole exome sequencing, whole genome sequencing). A total of 60 study-eligible subjects of all races and ethnicities ages 18 years or older will be enrolled in the non-lung cancer control subgroups chronic inflammatroy disorder (Cohort B), smokers at risk to develop lung cancer (Cohort C).

Eligibility: Inclusion Criteria:
  Cohort A (Lung Cancer Group)
  1. Stage IV Non-Small Cell Lung Cancer
  2. Adenocarcinoma histology
  3. Current or Former Smokers with greater than or equal to 10 pack year smoking history - See Appendix A)
  4. Candidates for standard or experimental treatment as determined by their treating physician
  5. Age 18 years and older
  6. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  Cohort B (Exercise Group)
  1. Age 18 years and older
  2. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  3. Ability to exercise for 30-40 minutes
  4. No Smoking history
  Cohort C (Chronic Inflammatory disease) Inclusion criteria:
  1. Chronic inflammatory disease including but not limited to:
  -  Systematic Lupus Erythematosus
  -  Rheumatoid arthritis
  -  Hepatitis C
  -  Ankylosing Spondylitis
  -  Scleroderma
  2. No history of smoking
  3. Age 18 years and older
  4. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  Cohort D (At risk for lung cancer)
  1. Age 55-74 years
  2. 30 or more pack-years of cigarette smoking history (Appendix A)
  3. Former smokers: quit smoking within the previous 15 years
  4. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  Exclusion Criteria:
  Cohort A (Lung Cancer Group)
  1. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
  2. Existing diagnosis or evidence of Diabetes Mellitus, Hepatitis C, Rheumatoid Arthritis or any previous solid organ transplant.
  3. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
  4. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
  5. Other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
  6. Other current malignancy(s). Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
  Cohort B (Exercise Group)
  1. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
  2. Existing diagnosis or evidence of Diabetes Mellitus, Hepatitis C, Rheumatoid Arthritis or any previous solid organ transplant.
  3. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
  4. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
  5. Other current malignancy(s). Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
  6. Known CAD (required surgery or stent placement in the last 6 months)
  Cohort C (Chronic inflammatory disease)
  1. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
  2. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
  3. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol.
  4. Other current malignancy(s). Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
  Cohort D (At risk for lung cancer)
  1. Other current malignancy(s). Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
  2. History of lung cancer
  3. History of removal of any portion of the lung, excluding needle biopsy
  4. Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment
  5. Recent hemoptysis
  6. Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment.
  7. Chest CT examination in the 18 months prior to eligibility assessment.
  8. Diagnosis of Diabetes Mellitus
  9. Chronic inflammatory disease including but not limited to:
  -  Systematic Lupus Erythematosus
  -  Rheumatoid arthritis
  -  Hepatitis C
  -  Ankylosing Spondylitis
  -  Scleroderma

Relevance to patient case: not relevant