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

Clinical trial: Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Summary: Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Detailed description: Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed Lung adenocarcinoma
  -  Wld-type EGFR
  -  Stage IIIB/IV
  -  Failure to prior chemotherapy
  -  Life expectancy of more than 3 months
  -  Tissue sample desired for genomic study
  -  Age ≥ 18 years
  -  Performance status (WHO) < 3
  -  Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
  -  Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  -  Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  -  Informed consent
  Exclusion Criteria:
  -  Have previously received pemetrexed or TKIs
  -  Other concurrent uncontrolled illness

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

Clinical trial: Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Summary: The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Detailed description: Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Eligibility: Inclusion Criteria:
  1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
  2. 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
  4. Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
  5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
  6. Total bilirubin 1.5 x upper limit of normal (ULN)
  7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
  9. If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.
  Exclusion Criteria:
  1. Mixed non-adenocarcinoma cell lung cancer histology
  2. Previous treatment with pemetrexed or tarceva
  3. Be allergic to pemetrexed or tarceva

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

Clinical trial: Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Summary: The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

Detailed description: This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
  -  No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
  -  Adequate organ and bone marrow function
  Exclusion Criteria:
  -  Prior chemotherapy or radiation therapy for NSCLC
  -  Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
  -  Patients with known hypersensitivity to other recombinant human antibodies
  -  History of stroke or transient ischemic attack (TIA).
  -  History of myocardial infarction or unstable angina within the past 12 months.
  -  Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
  -  Women who are pregnant or breast-feeding

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 Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer

Summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.


Eligibility: Inclusion Criteria:
  -  Adult patients, 18 years of age and older
  -  Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Life expectancy >3 months
  -  Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status (if unknown)
  -  Radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial.
  -  For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  -  For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  -  Adequate laboratory values
  Exclusion Criteria:
  -  HER2-positive tumor (primary tumor or metastasis)
  -  Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
  -  Prior treatment with investigational drugs that target the hepatocyte growth factor (HGF) or Met pathway
  -  History of other malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer
  -  Receipt of an investigational drug within 28 days prior to study start
  -  Clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., Crohn's disease)
  -  Significant history of cardiac disease
  -  Significant vascular disease
  -  Infection with human immunodeficiency virus, hepatitis B, or hepatitis C

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

Clinical trial: Nodal Status in Adenocarcinoma of the Esophagus an Cardia

Summary: Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM) and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor. The investigators retrospectively investigated the pathways of lymphatic spreading in 194 consecutive patients who received radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.

Detailed description: The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.
  Preoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station.

Eligibility: Inclusion Criteria:
  -  preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia
  -  preoperative from local to locally advanced disease
  -  absence of neoadjuvant therapy
  Exclusion Criteria:
  -  neoadjuvant therapy
  -  metastatic disease
  -  unfit for surgery

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

Clinical trial: Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Summary: This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed description: This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.
  Primary endpoint:
  Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib
  Secondary endpoint:
  1. Overall survival between icotinib and chemotherapy
  2. Time to Progression between icotinib and chemotherapy
  3. Objective response rate and disease control rate between icotinib and chemotherapy

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).
  Exclusion Criteria:
  -  Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung 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: Pulmonary Rehabilitation Before Lung Cancer Resection

Summary: This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).


Eligibility: Inclusion Criteria:
  -  Patient is scheduled to undergo a surgery for non small cell lung cancer
  -  Moderate to severe COPD
  -  Current or ex smoker of ten or more years
  Exclusion Criteria:
  -  Unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems Poorly motivated to attend the rehabilitation sessions or receive randomization.

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

Clinical trial: De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Summary: This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
  Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed description: Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.

Eligibility: Inclusion Criteria:
  1. Pathologically proven unresectable NSCLC
  2. 20 years of age or older
  3. Planned treatment with Iressa®
  4. Patients with activating EGFR mutation (del 19, L858R)
  5. Available detailed smoking history
  6. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
  7. Available blood sample
  8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
  9. Written informed consent
  Exclusion Criteria:
  1. More than 3rd line treatment
  2. Previously treated with other EGFR-TKI
  3. Life expectancy of less than 12 weeks
  4. Pregnant or lactating female
  5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
  6. Unsuitable patient in this treatment as determined by doctor.

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 Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

Summary: This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.


Eligibility: Inclusion Criteria:
  -  Heterogeneous emphysema with upper lobe predominance in both lungs
  -  FEV1 between 20% and 45% predicted
  -  Residual volume (RV) > 150% predicted
  -  Post-rehabilitation 6-minute walk test > 140 meters
  Exclusion Criteria:
  -  More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
  -  FEV1 < 20% predicted
  -  DLCO < 20% predicted or immeasurable DLCO
  -  Body mass index (BMI) < 18kg/m2 or > 32 kg/m2
  -  History of any of the following:
  -  Left ventricular ejection fraction (EF) ≤ 40%
  -  Stroke
  -  Myocardial infarction or acute coronary syndrome in previous year
  -  Hospitalization due to left ventricular failure in previous 3 years

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

Clinical trial: Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Summary: To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.


Eligibility: Inclusion Criteria:
  -  1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
  Exclusion Criteria:
  -  1. Active infection 2. Active bleeding

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 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ

Summary: This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.


Eligibility: Key Inclusion Criteria:
  -  Japanese subjects with pathologically confirmed unresectable locally advanced or metastatic carcinoma which is refractory to standard therapies or for which there is no standard therapy (Part 1 only)
  -  Japanese subjects with pathologically confirmed MET-positive (fulfilling the MET IHC criteria as defined by validated IVD [in vitro diagnostic]) unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1)
  -  Availability of archival tumor tissue (Part 2 only)
  -  Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria
  -  Able to tolerate infusions and take oral medications (Part 2 only)
  Key Exclusion Criteria:
  -  Previous systemic therapy (including chemotherapy, biologic, immunotherapy, or investigational therapy) for locally advanced or metstatic gastric or GEJ adenocarcinoma (Part 2 only)
  -  Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemotherapy to enrollment (Part 2 only)
  -  Squamos cell history (Part 2 only)
  -  Known HER2-overexpressing unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
  -  Resectable disease or suitable for definitive chemoradiation
  -  Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding (Part 2 only)
  -  Known central nervous system metastases

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

Clinical trial: Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

Summary: The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

Detailed description: The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
  The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
  It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Eligibility: Inclusion Criteria:
  -  Clinical and radiological evidence of emphysema
  -  Nonsmoking for 4 months prior to screening interview
  -  BMI less than 35 kg/m2
  -  Stable on current medication regimen
  -  Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
  Exclusion Criteria:
  -  Had two or more hospitalizations over the last year for a COPD exacerbation
  -  Had two or more hospitalizations over the last year for pneumonia
  -  Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  -  Had a heart attack or congestive heart failure within the last 6 months
  -  Have heart arrhythmia
  -  Is alpha-1 antitrypsin deficient

Relevance to patient case: not relevant