araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

Summary: The purpose of this study is to evaluate the value of induction Erlotinib therapy before thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Detailed description: Stage IIIA non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor.

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Histological or cytological documented
  -  Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
  -  Naive therapy NSCLC
  -  Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
  -  Enough tissue samples to perform gene analysis
  Exclusion Criteria:
  -  Small cell lung cancer
  -  Pregnant or breast-feeding women
  -  Any unstable systemic disease
  -  Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Detection of EGFR Mutations in the Blood of Patients With Non-small Cell Lung Cancer: a Feasibility Study

Summary: The overall objective of the study is to assess the feasibility of the use of blood for the detection of EGFR mutations in patients with non-small cell lung cancer (NSCLC)
  Specific aims are:
  1. To assess the use of immuno-separation techniques to enrich the tumor cell population in the blood of NSCLC patients.
  2. To assess the use of denaturing high performance liquid chromatography (DHPLC) assay for the detection of EGFR mutations in the blood of NSCLC patients.

Detailed description: The oral tyrosine kinase (TK) inhibitors of Epidermal Growth Factor Receptor (EGFR), gefitinib and erlotinib, have produced dramatic responses, encouraging response rates and possibly improved survival in a subset of NSCLC patients. Evidence suggests that somatic EGFR mutations in the tumor are at present the single most reliable biological marker of predicting response to EGFR TK inhibitors. In addition, these mutations may be an early event in the pathogenesis of NSCLC in a subset of patients. Unfortunately, the technology of EGFR mutations sequencing incurs high costs and requires sufficient tissue, which is often a problem in NSCLC. We hypothesize that EGFR mutations can be detected in the blood and propose a study to determine the feasibility of detecting EGFR mutations in the blood of NSCLC patients. We will approach newly diagnosed NSCLC patients as well as patients who are known to be responding to the oral TK inhibitors. We will perform EGFR mutations on the tumors. For the blood, we will use new immuno-separation techniques to isolate tumor cells and perform denaturing high performance liquid chromatography to detect EGFR mutations. If we prove that it is feasible to detect the mutations in the blood, we will follow up with a validation study. Many applications can result if our hypothesis holds true: 1) it will be proof of principle that our technique can effectively isolate and detect somatic mutations in circulating tumor cells, 2) it will be a simple way to overcome the problem of insufficient tumor samples, 3) it can be used for early detection of lung cancer if EGFR mutations proves to be important in pathogenesis in a subset of patients and 4) the technology can be extended to detect new mutations in patients who become resistant to oral TK inhibitors which can lead to new targeted therapies.

Eligibility: Patients with non small cell lung cancer.

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Summary: This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.


Eligibility: Inclusion Criteria:
  -  advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  -  progressed after 1-2 prior chemotherapy;
  -  Eastern Cooperative Oncology Group (ECOG) 0-2;
  -  tissue available for future KRAS/ EGFR testing
  Exclusion Criteria:
  -  prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  -  active or untreated Central Nervous System (CNS) metastases;

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib

Summary: Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.
  The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.
  In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.
  The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.

Detailed description: Aim:
  1. To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
  2. In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
  3. In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.

Eligibility: Inclusion Criteria:
  -  Patients who are starting treatment with erlotinib and who has who has signed the informed consent.
  Exclusion Criteria:
  -  None

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

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: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer

Summary: To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis


Eligibility: Inclusion Criteria:
  1. Age >18
  2. Histologically or pathologically proven non-small cell lung cancer (NSCLC)
  3. Leptomeningeal carcinomatosis confirmed by CSF cytology
  4. A patients with EGFR mutation (including exon 19 deletion, L858R)
  5. ECOG performance status 0-3
  6. Expected life time more than at least 4 weeks
  7. A patients who signed the informed consent prior to the participation in the study
  8. Chemotherapy-naïve patient is eligible
  9. Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases
  Exclusion Criteria:
  1. A pregnant or lactating patient
  2. A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
  3. A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
  4. A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
  5. A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
  6. A patient with history of allergic reaction to gefitinib or erlotinib
  7. The following laboratory test results:
  -  Number of absolute neutrophils counts (ANC) < 1.0ⅹ109/L
  -  Number of platelets < 50 ⅹ109/L
  -  AST, ALT > 2.5 ⅹupper limit of normal
  -  Total bilirubin > 1.5 ⅹupper limit of normal
  -  Serum creatinine > 1.5 ⅹupper limit of normal
  8. A patient with serious disease as followings
  -  Uncontrolled cardiac arrhythmia
  -  History of myocardial infarction within 6 months prior to the initiation of study
  -  Neurological or psychiatric disorder including dementia or uncontrolled seizure
  9. A patient who refused to sign the informed consent

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection

Summary: The aim of this study was to retrospectively evaluate associations between EGFR and AKT DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC patients treated with EGFR-TKIs.

Detailed description: DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.

Eligibility: Inclusion Criteria:
  -  Availability of tumor tissue or blood samples.
  -  Diagnosis of NSCLC
  -  At least one treatment with EGFR-TKIs inhibitors
  Exclusion Criteria:
  -  Other than NSCLC primary diagnosis
  -  No treatment with EGFR-TKIs inhibitors
  -  No archival tissue available

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer

Summary: RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
  PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
  -  To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.
  Secondary
  -  The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
  Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.

Eligibility: INCLUSION CRITERIA:
  -  At least 18 years of age or older
  -  Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb
  -  Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to Grade III) and within 2 years of the last radiation therapy treatment
  EXCLUSION CRITERIA:
  -  Patients with a pneumonectomy
  -  Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
  -  Use of an angiotensin II receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan
  -  Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension
  -  Patients taking lithium
  -  Currently smoking or smoked within 6 months of study entry
  -  Pregnant, intending to become pregnant or breastfeeding
  -  Baseline systolic blood pressure < 100 mmHg
  -  History of lung transplant
  -  History of kidney failure or liver disease
  -  Inability to attend clinic visits

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers.

Detailed description: OBJECTIVES:
  -  Measure plasma cathepsin D levels in patients with non-small cell lung cancer and in healthy volunteers using mass spectometry.
  -  Measure fatty acid synthase levels in these patients and healthy volunteers using mass spectometry.
  OUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry.

Eligibility: Inclusion Criteria:
  Non-Small Cell Lung Cancer Patients
  -  Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)
  -  Measurable disease by CT scan within the past 4 weeks
  Healthy volunteer
  -  Non-smoking, defined as < 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker
  -  Not regularly exposed (i.e., daily) to second-hand smoke
  Exclusion Criteria:
  -  Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV_1 < 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.
  Written consent must be given for both subjects and controls.

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
  -  Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.
  OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.

Eligibility: Inclusion criteria:
  1. Eligible patients had histologic documentation of un- treated stage III NSCLC.
  2. Radiation oncologist confirmation was required that radiation could be given per protocol.
  3. Eastern Cooperative Group Criteria Performance Status of 0 to 2
  4. Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
  5. Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines
  Exclusion criteria:
  1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.

Detailed description: OBJECTIVES:
  -  Examine the mutational status of the EGFR pathway in tumor and blood samples from patients with lung cancer.
  -  Correlate the EGFR pathway mutations in these samples with clinical outcomes of these patients.
  OUTLINE: Archived tumor tissue and blood samples are analyzed via PCR to detect EGFR pathway mutations in DNA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed lung cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  May have received prior EGFR inhibitors

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC).
  -  Estimate the frequency of EGFR mutation in these patients.
  -  Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block.
  OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed advanced non-small cell lung cancer
  -  Must have available tumor tissue block
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507

Summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung cancer specimens from clinical trial CASE-2507.
  -  Investigate EGFR DNA copy-number changes.
  -  Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as potential mechanisms of resistance.
  OUTLINE: This is a multicenter study.
  DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

Eligibility: DISEASE CHARACTERISTICS:
  -  Eligible for and concurrently enrolled on clinical trial CASE-2507
  PATIENT CHARACTERISTICS:
  -  Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  -  Normal coagulation profile and platelet count > 100,000/mm³*
  -  Not pregnant NOTE: *For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin)
  -  No concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet agents)* NOTE: *For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.

Relevance to patient case: possibly relevant