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

Clinical trial: Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

Summary: The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.


Eligibility: Inclusion Criteria:
  -  Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
  -  ≥ 18 years old
  -  patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
  -  At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
  -  have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
  -  ECOG 0-2
  -  Expected life time longer than 3 months
  -  Normal laboratory values:
  -  leucocyte≥ 4×109/L
  -  neutrophil≥ 1.5×109/L
  -  platelet≥90×109/L
  -  Hemoglobin≥ 9g/L
  -  ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
  -  serum creatinine<1.5 mg/dl
  -  bilirubin <1.5×ULN
  -  No allergy to biological drug
  -  Sign the consent forms
  Exclusion Criteria:
  -  Patients who have previously received Docetaxel or anti-VEGF inhibitors
  -  Severe symptomatic heart disease
  -  Female patients during their pregnant and lactation period, or patients without contraception
  -  Severe uncontrolled infection
  -  Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
  -  Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
  -  Patients have accepted other clinical trials

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 Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)

Summary: This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.


Eligibility: Inclusion Criteria:
  -  male patients, >/=18 years of age
  -  former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
  -  locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
  -  prior platinum-based therapy for advanced NSCLC
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  Exclusion Criteria:
  -  uncontrolled symptomatic central nervous system (CNS) metastases
  -  prior therapy against epidermal growth factor receptor (EGFR)
  -  >1 prior chemotherapy for advanced/metastatic NSCLC
  -  radiotherapy <28 days prior to enrollment
  -  history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of >5 years
  -  not fully treated eye inflammation or infection, or predisposing conditions

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 AMG 337 in Subjects With Advanced Solid Tumors

Summary: First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Men or women ≥ 18 years old
  -  Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
  -  Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing
  -  Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study)
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  -  Competent to sign and date an Institutional Review Board approved informed consent form
  -  Adequate hematologic and renal function as determined by laboratory blood and urine tests
  Exclusion Criteria:
  -  Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
  -  Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
  -  History of bleeding diathesis
  -  Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
  -  A baseline ECG QTc > 470 ms
  -  Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
  -  Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption
  -  Known positive test for HIV
  -  Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
  -  Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
  -  Major surgery within 30 days of study day 1
  -  Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Relevance to patient case: possibly relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Summary: Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.
  Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.
  The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
  -  patient with unresectable primary hepatocellular carcinoma
  -  Child-Pugh Class A or B, score ≤ 7
  -  ECOG score 0-2
  -  Expected survival time not less than 12 weeks
  -  At least one tumor nodule with one uni-dimension of ≥ 1 cm
  -  Peripheral platelet of or more than 50×10(9)/L
  -  Peripheral hemoglobin of or more than 85g/L
  -  Peripheral albumen of or more than 28g/L
  -  Total bilirubin ≤3.0mg/dl
  -  ALT and AST ≤ 5.0 x the upper limit of normal
  -  Serum amylase ≤ 1.5x the upper limit of normal
  -  Serum creatinine ≤ 1.5x upper limit of normal
  -  PT-INR<2.3 or PT prolong no more than 4s of normal
  Exclusion Criteria:
  -  Congestive heart failure > NYHA class 2
  -  History of active coronary disease( except myocardial infarction more than 6 months ago)
  -  Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
  -  uncontrollable hypertension
  -  Active clinically serious infections (> 2 NCI-CTC Version 3.0)
  -  History of HIV infection
  -  Inclined to hemorrhage or active hemorrhage with 1 month
  -  Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
  -  Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
  -  Known or suspected allergy to any agent given in association with this trial
  -  Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
  -  Surgical operation within 4 weeks prior to enrolling in this portion of the study

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 Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

Summary: This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.


Eligibility: Inclusion Criteria:
  -  Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer [AJCC])
  -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to (</=) 1
  -  Participants must
  1. be previously untreated for locally advanced/unresectable or metastatic melanoma or
  2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
  3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or expanded access programs (EAP) immediately prior to enrollment in this study or
  4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
  -  Life expectancy >/=12 weeks
  Exclusion Criteria:
  -  History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment
  -  Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment
  -  Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib
  -  Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study

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

Clinical trial: Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Summary: The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Detailed description: The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Non small cell lung cancer (NSCLC) - squamous cell
  -  Stage IV or recurrent NSCLC
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion Criteria:
  -  Brain Metastases
  -  Autoimmune diseases

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

Clinical trial: Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer

Summary: This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh.
  Sub-sites will be open for patient accrual in selected centers in the Kingdom.

Detailed description: The cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the United States, Europe and Asia. However, the safety and efficacy of this regimen was not studied systematically in Middle Eastern population. The aim of this study is to study the efficacy and safety of this regimen in our patient population

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven non-small cell lung carcinoma
  -  Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
  -  Patient should not be eligible for customization chemotherapy (if available at participating institutions).
  -  Having at least one measurable lesion
  -  Patient has life expectancy of 12 weeks or greater.
  -  Age > 18 years.
  -  No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.
  -  WHO performance status 0-2 (See Appendix III )
  -  Adequate organ function:
  -  Hematology: Neutrophils > 2 x 10 9 /L, platelets > 100 x 10 9 /L
  -  Hepatic function: Total bilirubin < 1.25 times the upper normal limits, ASAT (SGOT) < 2 times the upper normal limits
  -  Renal function: Creatinine < 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be > 60min/ml.
  -  Able to comply with scheduled follow-up and with management of toxicity
  -  Signed informed consent from patient or legal representative
  -  Negative urine pregnancy test (if indicated)
  Exclusion Criteria:
  -  Pregnant or lactating women or women of childbearing potential using inadequate contraception.
  -  Uncontrolled brain metastatic disease. (CNS disease that is stable > 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
  -  Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria Version 3
  -  Other serious illness or medical condition:
  -  Unstable cardiac disease requiring treatment
  -  History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures
  -  Active uncontrolled infection
  -  Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
  -  Concurrent treatment with any other anti-cancer therapy
  -  Contraindication of steroid drug administration
  -  Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix

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

Clinical trial: Common Safety Follow-up Trial of Tecemotide (L-BLP25)

Summary: This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA, EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25). Subjects were transferred once the feeder trial (EMR 63325-005 [NCT00157209], EMR 63325-006 [NCT00157196] and EMR 63325-008 [NCT01094548]) objectives were met. Subjects who received tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (PD) and survival in 6- month intervals. Subjects who had not received tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).


Eligibility: Inclusion Criteria:
  -  Signed written informed consent.
  -  Registration and treatment in a clinical trial with tecemotide (L-BLP25) under sponsorship of Merck KGaA/EMD Serono/Merck Serono Japan (feeder trial). [Note, subjects who have been allocated to treatments not containing tecemotide (L BLP25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (PD) (if applicable) and survival.]
  -  End of Treatment procedures have been performed in the feeder trial.
  -  Other protocol defined inclusion criteria could apply
  Exclusion Criteria
  -  Pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the Investigator. Subjects whom the Investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
  -  Known hypersensitivity to any of the trial treatment ingredients (if applicable)
  -  Legal incapacity or limited legal capacity
  -  Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
  -  Other protocol defined exclusion criteria could apply

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

Clinical trial: Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

Summary: Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma


Eligibility: Inclusion Criteria:
  -  Age 18 years or older
  -  ECOG performance score of two or less
  -  Child Pugh class A•
  -  Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL
  -  presence of extrahepatic measurable lesion
  -  no prior systemic therapy (excluding sorafenib)
  -  adequate marrow, liver, kidney function
  -  written informed consent
  Exclusion Criteria:
  -  prior systemic therapy (excluding sorafenib)
  -  hypersensitivity to study drugs
  -  active gastrointestinal bleeding
  -  other malignancies within five years
  -  pregnant or breastfeeding female
  -  symptomatic brain or leptomeningeal metastasis
  -  clinically significant heart disease
  -  interstitial pneumonia
  -  peripheral neuropathy grade one or more
  -  uncontrolled infection
  -  renal impairment
  -  prior use of investigational drug or therapy within 4 weeks

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 Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

Summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult participants, greater than or equal to (>/=) 18 years of age
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
  -  Met diagnostic-positive status tested by immunohistochemistry (IHC)
  -  Results of endothelial growth factor receptor (EGFR)-activating mutation testing
  -  Radiographic evidence of disease
  -  Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
  -  availability of tissue sample for diagnostic testing is required
  Exclusion Criteria:
  -  More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
  -  Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
  -  History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible
  -  Inadequate hematological, biochemical or organ function
  -  Significant history of cardiac disease
  -  Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
  -  Any inflammatory changes of the surface of the eye
  -  Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
  -  Pregnant or lactating women
  -  Positive for human immunodefinciency (HIV) infection

Relevance to patient case: definitely relevant