araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Summary: This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer. The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of adenocarcinoma.

Detailed description: To participate in this study, patients must have disease that can be measured on a CT scan. Brain metastases are OK if stable. Pregnant and/or nursing women may not participate. This drug has been approved by the FDA for the treatment of advanced renal cell cancer and a certain type of stomach/intestinal cancer. Its efficacy in lung cancer in currently unknown. Common side effects include fatigue, nausea, diarrhea, skin reaction, and decreased blood counts.

Eligibility: Inclusion Criteria:
  -  Bronchoalveolar carcinoma with disease measurable on CAT scan
  -  Any lung adenocarcinoma in a never-smoker (less than 100 cigarettes lifetime) with disease measurable on CAT scan
  -  Stage IIIB or IV
  Exclusion Criteria:
  -  Uncontrolled hypertension
  -  Unstable brain metastases
  -  Pregnant/nursing women
  -  Uncontrolled thyroid disease

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

Summary: Open label study of sorafenib

Detailed description: Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than < 100 cigarettes lifetime).

Eligibility: Inclusion Criteria:
  -  Age > 18
  -  Life expectancy > 12 weeks
  -  Biopsy-proven BAC or adenocarcinoma
  -  Willing to provide smoking status
  -  Selected IIIB or stage IV cancer that is incompletely resected or unresectable
  Exclusion Criteria:
  -  O2 saturation < 88% on room air
  -  Pregnant or nursing women
  -  Surgery or radiation therapy within 4 weeks of starting study
  -  Major heart condition within 6 months of starting therapy
  -  Certain concomitant medications prohibited

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Summary: A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.


Eligibility: Inclusion Criteria:
  1. Confirmed metastatic colorectal adenocarcinoma
  2. Not amenable to surgery or radiation therapy
  3. Eligible for first or second line chemotherapy
  Exclusion Criteria:
  1. Brain metastases or spinal compression
  2. Last prior chemotherapy discontinued within 4 weeks before start
  3. Last dose radiotherapy within 4 weeks of start

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
  -  Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
  -  Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)
  Exclusion Criteria:
  -  Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
  -  Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
  -  Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Sequential Endoscopic Lung Volume Reduction

Summary: Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Detailed description: Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.
  Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30

Eligibility: Inclusion Criteria:
  -  Heterogenous emphysema
  -  FEV1 < 45%
  -  RV > 150%
  -  TLC > 100%
  -  TLCO < 40%
  Exclusion Criteria:
  -  Homogeneous emphysema
  -  Pregnancy
  -  PCO2 > 50 mmHg

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Evaluating the Effects of Surgical and Non-Surgical Treatment Options in People With Emphysema

Summary: Emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to breathing difficulties. Treatment options for people with emphysema include pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation. This study will observe people with emphysema to assess the effect of these treatment therapies on their quality of life and long-term health.

Detailed description: Emphysema is a progressive lung disease that results in shortness of breath and a reduced capacity for physical activity. It is caused by inflammation within the small air sacs and small airways of the lungs, which can lead to the destruction of the air sac walls and eventually to airway collapse. Treatment options for emphysema include both non-surgical and surgical interventions. Pulmonary rehabilitation, a non-surgical treatment, includes a combination of education, exercise training, nutrition advice, and smoking cessation programs. The goal of pulmonary rehabilitation is to increase exercise tolerance and reduce breathing difficulties. Two surgical treatment options include lung volume reduction surgery, in which small amounts of damaged lung tissue are removed, and lung transplantation, in which a person's damaged lung is replaced with a healthy lung from a donor. While these surgical options may offer potential improvements in quality of life, they also impose substantial risks, including infections, pneumonia, or even death. In this study, researchers will follow participants over a long period of time to assess the effects of pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation on health outcomes and quality of life.
  This study will enroll people with moderate to severe emphysema who have undergone pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation. Participants will attend annual study visits and will complete computerized interviews and health-related questionnaires that will assess quality of life factors. Study researchers will also review participants' medical records to collect information on lung function and blood test results.

Eligibility: Inclusion Criteria:
  -  Diagnosed with emphysema
  -  Referred for pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation
  Exclusion Criteria:
  -  Non-obstructive lung disease
  -  Chronic obstructive pulmonary disease (COPD) that is not predominantly due to emphysema
  -  Inability to read English

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

Summary: The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).


Eligibility: Inclusion Criteria:
  -  Heterogeneous emphysema as determined by high-resolution CT scan
  -  Scheduled for clinically indicated ELVR procedure
  Exclusion Criteria:
  -  Hyperexcretive chronic bronchitis or excessive sputum secretion
  -  Active pulmonary infection
  -  Active asthma or lung hyper-responsiveness

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

Summary: In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.

Detailed description: MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.
  In this study, MGCD265 is orally administered on a daily basis to patients with advanced malignancies.

Eligibility: Inclusion Criteria:
  -  Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
  -  Evaluable disease;
  -  Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
  -  Recovery from the adverse effects ≤ grade 1;
  -  Acceptable ECOG status 0, 1, or 2;
  -  Life expectancy greater than 3 months following study entry;
  -  Adequate laboratory values;
  -  For patients enrolling in the four expansion cohorts:
  -  NSCLC patients must meet criteria for MET and/or Axl expression or,
  -  HNSCC patients must meet criteria for MET and/or Axl expression or,
  -  NSCLC patients must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
  -  Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus
  Exclusion Criteria:
  -  Uncontrolled concurrent illness;
  -  History of cardiovascular illness;
  -  QTc > 470 msec (including subjects on medication);
  -  Left ventricular ejection fraction (LVEF) < 50%;
  -  Immunocompromised subjects;
  -  History of bone marrow transplant;
  -  Lung tumor lesions with increased likelihood of bleeding;
  -  Symptomatic or uncontrolled brain metastases;
  -  Unable to swallow oral medications or with pre-existing gastrointestinal disorders.

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

Summary: This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.


Eligibility: Inclusion Criteria:
  -  Advanced adenocarcinoma of lung, measurable disease
  -  Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  -  patients with known EGFR activating mutation regardless of smoking status
  -  ECOG(Eastern Cooperative Oncology Group) 0-1.
  Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
  Exclusion Criteria:
  -  Active brain metastases
  -  Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  -  known EGFR wild type NSCLC

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Alveolar Macrophage Proteomics in HIV-associated Emphysema

Summary: This study is being done to examine lung function changes in individuals with HIV infection and to understand why individuals with HIV have increased risk of lung damage from cigarette smoking.

Detailed description: To delineate the natural history of HIV associated emphysema in the HAART era. To compare the alveolar macrophage proteomes from HIV-seropositive smokers with emphysema to the alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.
  To establish whether coinfection with HIV and Hepatitis C results in accelerated lung disease manifested by decrements in forced expiratory volume and carbon monoxide diffusing capacity.

Eligibility: Inclusion Criteria:
  -  Clinically stable HIV-seropositive (and HIV-seronegative) individuals
  -  Ages 18 years and older
  -  Female subjects on no oral contraception with a negative pregnancy test
  -  Subjects capable of giving written consent
  Exclusion Criteria:
  -  Known medical illness that would preclude bronchoscopy/BAL (e.g. unstable angina, new cardiac arrhythmia). This only pertains to subjects involved in the bronchoscopy phase of the study.
  -  Pregnant females
  -  Prisoners

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer

Summary: A biobank of Serum, plasma, DNA samples together with clinical information including specific questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in patients seen at the investigators' clinical service.
  The objective is to study candidate gene pathways in COPD and or lung cancer and to associate them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.
  In subgroups of well characterised patients, other biological materials are also collected (lung tissue biopsies, peripheral blood mononuclear cells).

Detailed description: All patients with a smoking history of at least 15 pack years, an minimal age of 50 years and an recent available CT scan are enrolled.
  All subjects with a diagnosis of lung cancer are also collected (irrespective of age and smoking behavior).
  In addition the investigators collect:
  -  specific questionnaires (MRC, CCQ and smoking history)
  -  medical and professional history
  -  complete pulmonary function (spirometry, bodyplethysmography and diffusing capacity)
  -  serum, plasma and DNA samples.
  In specific subgroups the investigators also collect:
  -  Peripheral blood mononuclear cells
  -  Lung tissue - if available - from a surgical procedure (lung transplantation or lobectomy)

Eligibility: Inclusion Criteria for smokers:
  -  A smoking history of at least 15 pack years and age of 50 years or older
  -  Complete pulmonary function on day of visit
  -  Chest CT-scan within one year of enrollment
  -  4 weeks from exacerbation
  Exclusion Criteria for smokers:
  -  Less than 15 pack years
  -  Younger than 50 year
  -  Other pulmonary diseases interfering with CT or pulmonary function
  -  Asthma
  Inclusion Criteria for lung cancer patients:
  -  new diagnosis of proven lung cancer
  -  chest CT scan within 2 months of enrollment
  -  Complete pulmonary function
  Exclusion Criteria for lung cancer patients
  -  not able to perform pulmonary function
  -  Absence of histological diagnosis of lung cancer

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

Summary: Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.


Eligibility: Inclusion Criteria:
  -  Male or female, 40-75 yrs old,inclusive.
  -  Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
  -  FEV1: FVC greater than 70% predicted.
  -  At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
  -  Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.
  Exclusion Criteria:
  -  Patients with asthma, active tuberculosis or bronchiectasis.
  -  A respiratory tract infection within 30 days prior to the screening visit.
  -  Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
  -  Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
  -  Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
  -  Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
  -  Subjects taking anticoagulants.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

Summary: This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Detailed description: Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma

Eligibility: Inclusion Criteria:
  -  Patients age 18 years or more.
  -  Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
  -  Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
  -  Tumor sample available.
  -  A measurable lesion, as defined by RECIST criteria.
  -  Karnofsky score 60% or more (ECOG < 2).
  -  Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
  -  Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
  -  Patients with hepatical, renal and hematology normality values.
  -  Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
  -  Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
  -  Patients must be available for clinical follow-up..
  Exclusion Criteria:
  -  Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
  -  Severe comorbidity.

Relevance to patient case: not relevant