araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

Summary: Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.


Eligibility: For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria: - 18 years of age or older. - Pathological diagnosis of NSCLC. - Bidimensionally measurable disease. - Tumor tissue available for immunohistochemistry studies. - Tumor over-expressing EGFR as ascertained by immunohistochemistry. - Disease stage IIIB with pericardial or pleural effusion, or stage IV. - Life expectancy of at least 12 weeks. - Adequate hematology function - Adequate renal function - Adequate hepatic function - ECOG score of less than 2. - Brain metastases, if present; must be controlled and asymptomatic. Exclusion Criteria: - Calcium > ULN (treatment for hypercalcemia allowed). - Use of any investigational therapy within 30 days of ABX-EGF infusion. - Any cancer therapy for NSCLC other than radiation therapy, surgery, or steroids. - Radiation therapy within 2 weeks before ABX-EGF infusion. - LVEF less than 45% as measured by MUGA. - Symptomatic ventricular arrhythmia or symptomatic conduction abnormality. - Myocardial infarction within 1 year before first dose of study drug. - History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ. - Women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an IUD during the course of the study and for 6 months following treatment. - Men not willing to use contraception upon enrollment into this study and for 1 month following treatment. - Women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration. - Known to be HIV positive. - Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

Summary: Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Histologic confirmation of non-small-cell lung cancer
  -  Stable systemic disease
  -  Maximum of one prior chemotherapy regimen for metastatic systemic disease
  -  Radiotherapy for local control or palliative bony lesions is allowed
  -  Karnofsky of greater than or equal to 70%
  -  Adequate hematologic, renal and liver function
  Exclusion Criteria:
  -  Patients eligible for surgery of the brain
  -  Any previous chemotherapy for the brain metastasis
  -  Chemotherapy within 4 weeks or previous temozolomide
  -  Prior radiotherapy to the brain
  -  Radiation therapy to greater than 50% of the bone marrow
  -  Insufficient recovery from previous therapies
  -  Active nonmalignant systemic disease
  -  Inability to take oral medication
  -  Pregnant or nursing women
  -  Non use of adequate contraceptive techniques, negative urine pregnancy test is required
  -  Known AIDS related illness

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer

Summary: CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.


Eligibility: Inclusion Criteria:
  -  Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer.
  -  No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer.
  -  Original or recent tumor tissue must be available.
  -  Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks.
  -  Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor).
  -  Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug.
  Exclusion Criteria:
  -  Unstable medical condition
  -  prior chemotherapy within 4 week of screening
  -  series infection
  -  other tumor types
  -  ECOG performance status of 3 or 4.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer

Summary: Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma.
  This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly.
  The purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.


Eligibility: Inclusion criteria:
  -  Confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed.
  -  No prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers
  -  No previous irradiation to the only area of measurable disease.
  Exclusion Criteria:
  -  Past or current history of neoplasm other than the entry diagnosis. Exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years.
  -  Patients who have undergone surgery less than 3 weeks prior to enrollment.
  -  History of serious cardiac disease not adequately controlled.
  -  Patients with serious active infections or other serious underlying medical condition.
  -  Uncontrolled diabetes mellitis.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

Summary: A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

Detailed description: A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Eligibility: INCLUSION CRITERIA
  -  newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
  -  ECOG performance status 0-1
  -  adequate organ function
  -  clinically indicated and able to receive conventional chemoradiation therapy
  EXCLUSION CRITERIA
  -  patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
  -  patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Non-small Cell Lung Cancer Registry

Summary: This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.


Eligibility: Inclusion Criteria:
  -  Age greater than or equal to 18 years
  -  Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
  -  Unresectable Stage IIIB with pleural effusion or stage IV NSCLC
  -  ECOG performance status of 0 or 1
  Exclusion Criteria:
  -  Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)
  -  Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
  -  Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
  -  Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
  -  Abnormal renal function or creatinine clearance
  -  Unstable brain metastasis
  -  Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
  -  Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Summary: The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
  A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
  Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years old
  -  ECOG score of 0, 1, or 2
  -  Histologically confirmed diagnosis of non-small cell lung cancer
  Exclusion Criteria:
  Laboratory values demonstrating inadequate function of the following:
  -  Bone marrow
  -  Kidneys
  -  Liver
  and
  -  Peripheral neuropathy Grade 2 or higher
  -  Greater than 2 prior chemotherapy regimens

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

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: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)

Summary: The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

Detailed description: Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
  -  Invasion to the first rib or more superior chest wall
  -  Age: 15-74 years old
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Ample organ function
  -  No prior chemo- or radiotherapy
  -  Signed informed consent
  Exclusion Criteria:
  -  Metastasis to, or involvement of, mediastinal node (N2)
  -  Distant metastasis or dissemination to pleura/pericardium
  -  Active concomitant malignancy
  -  Unstable angina, recent myocardial infarction, heart failure
  -  Uncontrolled diabetes or hypertension
  -  Pregnant or lactating women
  -  Other severe complications

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer

Summary: A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.

Detailed description: This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer.
  In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791.
  If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.
  Participants will be followed up longterm, so that survival can be measured.

Eligibility: Inclusion Criteria:
  -  Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma.
  -  The subject must be aged 18 years or above.
  -  The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
  -  Subjects will have measurable disease.
  -  The subject must be able to understand the information provided to them and to give written informed consent.
  -  Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator.
  -  Male subjects must be using a method of contraception judged reliable by the Investigator.
  Exclusion Criteria:
  -  Subjects with squamous cell lung carcinoma.
  -  Subjects with lung lesions located centrally in the chest that involve major blood vessels.
  -  Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
  -  Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
  -  Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2.
  -  Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.

Summary: The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility: Inclusion Criteria:
  -  Non small cell lung cancer, Stage IIIB or Stage IV
  -  One and only 1 prior platinum-based chemotherapy
  -  No other uncontrolled concurrent illness
  -  Use of highly effective birth control methods in males or females with reproductive potential
  Exclusion Criteria:
  -  Previous participation in another trial within the last 4 weeks
  -  Surgery within 10 days prior to the start of study treatment
  -  Brain metastases
  -  Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
  -  Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
  -  Breast feeding

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Summary: The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for subject with non small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Subjects with advanced or metastatic non small cell lung cancer.
  -  Subjects should have had at least one prior chemotherapy with a platinum based therapy.
  Exclusion Criteria:
  -  Subjects are excluded from this study if they do not have non small cell lung cancer that is advanced or metastatic or have not had at least one prior platinum based chemotherapy.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)

Summary: Determination of response rate Assessment of toxicity and determination of "time to progression"

Detailed description: Phase II Study to determine the efficacy of Bendamustin(Ribomustin) in patients with recurrent small cell bronchial carcinoma after cytostatic polychemotherapy

Eligibility: Inclusion Criteria:
  -  Patients with histological proven, curative non treatable small lung cell carcinoma
  -  Recurrence >8 weeks, > 1 year after 1st line treatment with platin- and etoposide polychemotherapy, without brain metastases
  Exclusion Criteria:
  -  Brain metastases
  -  WHO-PS 3 - 4

Relevance to patient case: not relevant