araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

Summary: The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of:
  -  Advanced solid tumor that is no longer responding to therapies OR
  -  Advanced or metastatic NSCLC that has previously been treated with erlotinib or gefitinib
  -  ECOG Performance Status 0-1
  -  Adequate organ and bone arrow function as defined by hematological and serum chemistry limits
  -  At least 18 years old
  -  Both men and women must practice adequate contraception
  -  Informed consent
  Exclusion Criteria:
  -  Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
  -  Erlotinib intolerant
  -  Taking oral corticosteroids chronically or > 1 mg/day warfarin
  -  Not recovered from the toxic effects of prior therapy
  -  History of diabetes mellitus and an HgbA1c > 7%
  -  Uncontrolled intercurrent illness
  -  Pregnant or breastfeeding
  -  Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
  -  HIV positive
  -  Diagnosis of another malignancy may exclude subject from study

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Biomarker Study of Blood Samples From Patients With Non-Small Cell Lung Cancer Treated With Carboplatin and Paclitaxel With or Without Bevacizumab

Summary: RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for non-small cell lung cancer may help doctors predict how patients will respond to treatment.
  PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from patients undergoing treatment for non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To develop a serum proteomic classifier using matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry analysis of blood samples from patients with non-squamous cell non-small cell lung cancer to predict benefit, in terms of survival and time to progression, from treatment with bevacizumab in combination with carboplatin and paclitaxel.
  Secondary
  -  To better quantitate candidate biomarkers by using more advanced mass spectrometric technologies, including multiple-reaction monitoring and heavy-labeled peptides.
  OUTLINE: Previously collected pre-treatment samples of serum or plasma are randomly selected from patients enrolled on protocol ECOG-4599 (i.e., 60 from the bevacizumab arm and 30 from the control arm). Samples are analyzed by matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry to identify patterns from protein spectra that correlate with patient survival.

Eligibility: DISEASE CHARACTERISTICS:
  -  Available serum and plasma samples from patients with previously untreated locally advanced, metastatic, or recurrent non-squamous cell non-small cell lung cancer
  -  Enrolled on clinical trial ECOG-4599
  -  Treated with carboplatin and paclitaxel with or without bevacizumab
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)

Summary: This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
  -  Stage IIIA patients with technical operable disease evaluated by image and lab results;
  -  Patients without chemotherapy or targeted-therapy before;
  -  Inform Consent.
  Exclusion Criteria:
  -  Patients with malignant tumor other than lung cancer;
  -  Patients with other diseases such as cardiovascular disease that may hamper follow up;
  -  Patients that may not coordinate well,judged by researcher.

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Summary: A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Detailed description: Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.
  Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Eligibility: Inclusion Criteria:
  -  Patients with locally advanced or metastatic non-small cell lung cancer.
  -  Patients must be >/= 18 years of age.
  -  Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
  Exclusion Criteria:
  -  Patients with a recent history (within 5 years) of another malignancy.
  -  Patients who are pregnant or nursing.
  -  Patients with clinically significant heart failure.
  -  Patients with clinically significant eye or gastrointestinal abnormalities.

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer

Summary: The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Detailed description: Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
  Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
  -  Patients with central tumors located at the origin of a lobar bronchus.
  -  ECOG performance status 0-1
  -  Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
  -  Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
  -  Renal: Creatinine clearance greater than 60 ml/min
  -  Cardiovascular: Cardiac function normal
  Exclusion Criteria:
  -  Severe complications or infections
  -  Pregnant or breast-feeding women
  -  Clinically significant heart disease
  -  Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
  -  Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

Relevance to patient case: not relevant