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

Clinical trial: Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Detailed description: Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
  -  Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
  -  Measurable disease per RECIST criteria.
  -  Adequate bone marrow, hepatic and renal function.
  Exclusion Criteria:
  -  Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
  -  Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
  -  Known hypersensitivity to minocycline.
  -  History of serious cardiac disease that is not controlled.
  -  Serious eye conditions.
  -  Prior treatment with inhibitors of EGFR of any kind.

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

Clinical trial: Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Summary: The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of advanced solid tumors that are refractory to at least 1 standard therapy or for which no standard therapy is available and have not received more than 3 prior treatment regimens (not inclusive of hormonal therapies for breast and prostate cancer subjects) for the advanced solid tumor (tumor must be diagnosed by standard criteria for the specific tumor type)
  -  Measurable disease or evaluable (non-measurable) disease per RECIST guidelines (all sites of disease must be evaluated within 28 days before enrollment)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Life expectancy of > 3 months as documented by the investigator
  -  If history of other primary cancer, subject will be eligible only if she or he has:
  -  Non-melanomatous skin cancer, not requiring treatment
  -  Curatively treated cervical carcinoma in situ
  -  Other primary solid tumor curatively treated with no known active disease present for the last 5 years and no treatment administered for the last 3 years
  -  Man or woman 18 years of age or older
  -  Paraffin-embedded tumor tissue (from primary or metastatic tumor tissue) available for immunohistochemistry studies of EGFr expression (biopsy or archived tissue are acceptable). The immunohistochemical EGFr staining and evaluation must be conducted at the designated central laboratory using the DakoCytomation EGFR pharmDXTM kit. Local laboratory EGFr expression is not permitted for the purpose of eligibility in this study
  -  Hematologic function, as follows:
  -  Absolute neutrophil count (ANC) > 1.5 x 109/L
  -  Platelet count > 100 x 109/L
  -  Hemoglobin > 8 g/dL
  -  Renal function, as follows:
  o Creatinine < 2.0 mg/dL
  -  Hepatic function, as follows:
  -  Aspartate aminotransferase (AST) < 3 x ULN (if liver metastases ≤ 5 x ULN)
  -  Alanine aminotransferase (ALT) < 3 x ULN (if liver metastases ≤ 5 x ULN)
  -  Bilirubin < 2 x ULN
  -  Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form

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

Clinical trial: Study of Tarceva and Targretin in Stage I-II Lung Cancer

Summary: The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Detailed description: Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Eligibility: Inclusion Criteria:
  -  Resectable stage I or II non-small-cell lung cancer
  -  Prior tissue biopsy (not cytology) available for research analysis
  -  Adequate hepatic and renal function
  Exclusion Criteria:
  -  Prior chemotherapy or radiotherapy

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 In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Summary: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced/metastatic non-small cell lung cancer
  -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
  Exclusion Criteria:
  -  Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  -  History of or known brain 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: Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
  -  Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
  -  ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
  -  Tumor sample available and adequate for analysis.
  -  At least one measurable target lesion.
  -  Adequate cardiac, kidney, and liver function
  -  Adequate blood counts
  Exclusion Criteria:
  -  More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
  -  Significant cardiac disease or dysfunction.
  -  Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.
  -  Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
  -  Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
  -  Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
  -  Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
  -  Inability or unwillingness to swallow HKI-272 capsules.
  -  Pregnant or breastfeeding women.

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

Clinical trial: Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

Summary: This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.


Eligibility: Inclusion Criteria:
  -  Age >= 18
  -  Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  -  Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
  -  Radiologically measurable or evaluable disease No prior chemotherapy
  -  1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
  -  Tumor tissue block or fine needle aspirate
  Exclusion Criteria:
  -  Any concurrent anticancer therapy or radiation
  -  Other active malignancy
  -  Uncontrolled brain metastases
  -  GI abnormalities
  -  Severe abnormalities of the cornea
  -  Significant cardiac disease
  -  Active infection

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

Clinical trial: ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer

Summary: This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.
  This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.
  All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.
  In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.
  Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.
  Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.


Eligibility: Inclusion Criteria:
  Lung cancer patients who answer true to the following statements are eligible to join this clinical study.
  -  I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
  -  I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.
  Exclusion Criteria:
  Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.
  -  I do not have non small cell lung cancer (NSCLC)
  -  I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
  -  I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
  -  I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
  -  I have a history of uncontrolled irregular heartbeat
  -  I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.

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

Clinical trial: Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

Summary: To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.


Eligibility: Inclusion Criteria:
  -  Advanced, EGFR-positive NSCLC
  -  ECOG Performance Status 0, 1 or 2
  -  Measurable disease
  Exclusion Criteria:
  -  Known CNS metastasis
  -  Pre-existing autoimmune or antibody mediated disease

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

Clinical trial: Study of XL647 Administered Orally Daily to Patients With Solid Tumors

Summary: The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Subject has histologically confirmed malignancy that is metastatic or unresectable
  -  Subject has disease that is assessable by tumor marker, physical, or radiologic means
  -  Subject is at least 18 years old
  -  Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  -  Subject has a life expectancy ≥ 3 months
  -  Subject has normal organ and marrow function
  -  Subject gives written informed consent
  -  Subject must use an accepted method of contraception during the study
  -  Female subjects of childbearing potential must have a negative pregnancy test
  Exclusion Criteria:
  -  Subject has received anticancer treatment within 30 days of first dose of XL647
  -  Subject has received another investigational agent within 30 days of first dose of XL647
  -  Subject has known brain metastases
  -  Subject has corrected QT interval (QTc) of > 0.45 seconds
  -  Subject is currently receiving anticoagulation therapy with warfarin
  -  Subject has uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Subject has known HIV

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

Clinical trial: Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Summary: The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility: Inclusion Criteria:
  -  Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1
  -  Normal organ and marrow function
  -  No other malignancies within 5 years, except for non-melanoma skin cancer
  Exclusion Criteria:
  -  Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
  -  Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
  -  Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
  -  Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
  -  The subject meets any of the following cardiac criteria:
  -  Corrected QT interval (QTc) of > 460 msec
  -  Family history of congenital long QT syndrome or unexplained sudden death
  -  History of sustained ventricular arrhythmias
  -  Has a finding of left bundle branch block
  -  Has an obligate pacemaker
  -  Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  -  Has uncontrolled hypertension
  -  Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  -  Has a serum potassium or serum magnesium level that falls outside the normal range
  -  The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
  -  Uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Known HIV

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

Clinical trial: Effect of BIBW 2948 BS in COPD

Summary: Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis


Eligibility: Inclusion Criteria:
  -  COPD smokers
  -  ages between 40 and 70
  Exclusion Criteria:
  -  Significant other diseases
  -  abnormal hematology
  -  abnormal liver function
  -  psychiatric disorders
  -  pulmonary obstruction
  -  asthma, allergic rhinitis
  -  dependance on oxygen
  -  patients with history of myocardial infarction
  -  patients with history of cancer
  -  women of child bearing potential
  -  antiplatelet or anticoagulation therapy

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

Clinical trial: Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

Summary: RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.
  PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

Detailed description: OBJECTIVES:
  -  Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.
  OUTLINE: This is a prospective study.
  Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer
  -  Any disease stage allowed
  -  Undergoing targeted treatment
  Exclusion Criteria:
  None

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 Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.


Eligibility: Inclusion Criteria:
  -  adult patients >=18 years of age;
  -  histologically documented, locally advanced or recurrent or metastatic NSCLC;
  -  measurable disease;
  -  disease progression during 1-4 cycles of platinum-based chemotherapy.
  Exclusion Criteria:
  -  any other malignancies within the last 5 years;
  -  unstable systemic disease.

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

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:
  -  None

Relevance to patient case: possibly relevant