araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Phase 2, Multicenter, Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label

Summary: Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.


Eligibility: Inclusion Criteria
  -  Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer staging criteria).
  -  Measurable disease according to RECIST v.1.1.
  -  An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.
  -  BDX004 Positive Label.
  -  Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or biologic therapy for metastatic NSCLC. Subjects may have previously been treated with postoperative adjuvant chemotherapy for early stage lung cancer or chemo radiotherapy for locally advanced disease provided this was completed at least 6 months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria
  -  History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or erlotinib.
  -  History of known brain metastases.
  -  Prior treatment with any other investigational drug or biologic agent within 5 half lives prior to randomization, or any investigational device within 2 weeks prior to randomization.
  -  Any unresolved toxicity from previous radiation therapy.
  -  Significant cardiovascular disease, including:
  -  Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left ventricular ejection fraction of less than 55%.
  -  Cardiac failure New York Heart Association class III or IV.
  -  Myocardial infarction, severe or unstable angina within 6 months prior to randomization.
  -  History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation).
  -  Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack).
  -  Any uncontrolled or severe cardiovascular disease.
  -  History of prior malignancy within 3 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
  -  Radiographic evidence of interstitial lung disease.

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: An epidemiOlogy Study to deteRmine the Prevalence of EGFR (Epidermal Growth Factor Receptor) muTations in RUSsian Patients With Advanced NSCLC (Non-Small Cell Lung Cancer).

Summary: This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia.

Detailed description: This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
  It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years.
  EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.

Eligibility: Inclusion Criteria:
  -  Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study
  -  Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
  -  No previous/ ongoing treatment for NSCLC at the moment of recruitment
  Exclusion Criteria:
  -  Squamous NSCLC cytologically confirmed subtype of cancer
  -  Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
  -  Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Summary: 300 patients with colorectal cancer will be investigated before surgery and 60 of them will also be investigated in the same manner after surgery. Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and a questionnaire, but only before surgery including questions on sleep, sleep apnea, lung disorders.
  Outcome: side effects of surgery and mortality rate, association with cancer type.
  Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after surgery.

Detailed description: Group 1. Inclusion: 240 patients with colorectal cancer scheduled for surgery. Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before surgery with Lung-function measurements, blood-gas sample, questionnaire, Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality, Sleep apnea, hypxoia, hyprecapnia and effect on lungfunction (VC, FEV1). Detailed morphologic analysis of cancer type.
  Group 2. Inclusion: 35 patients with colorectal cancer scheduled for open surgery, Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.
  Group 3. Inclusion: 25 patients with colorectal cancer scheduled for laparoscopic or robot surgery.
  Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for surgery of colorectal cancer
  Exclusion Criteria:
  -  Dementia, CPAP treatment for obstructive sleep apnea

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?

Summary: There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one lung ventilation. The overloading of fluid administration could be related to the development of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability of stroke volume variation as an indicator for a fluid responsiveness in patient who receives pulmonary lobectomy via thoracotomy.

Detailed description: Perioperative fluid management during thoracic surgery is a significantly important, because it is quite difficult to prevent pulmonary edema due to the fluid overload and compromise perfusion of vital organ. So, it is essential to maintain optimal organ perfusion by appropriate fluid management during thoracic surgery. Stroke volume variation (SVV) is derived from pulse contour analysis and it is known that SVV ≥12~15% correlate with fluid responsiveness, defined as a significant increase in cardiac output with fluid loading, dung two-lung ventilation. It is a parameter derived from changes in stroke volume (SV) that is according to the heart-lung interaction during mechanical ventilation. positive pressure ventilation induces cyclic changes in left ventricular SV that are related mainly to the expiratory decrease in right ventricular filling and ejection. This is a reflected by variations in the SV. However both ventilator issues, such as tidal volume, PEEP, chest and lung condition, and the cardiovascular condition, such as heart rate, rhythm, ventricular function, cardiac afterload, arterial compliance may affect SVV. Recently some studies reported that SVV could predict fluid responsiveness in mechanically ventilated patients under various conditions. But it is still unclear whether SVV could predict fluid responsiveness during one lung ventilation with the chest open via a thoracotomy. During one-lung ventilation, the shunted blood flow through the non-ventilated-lung dose not contribute to the generation of SVV. And with the chest opening by thoracotomy, the pressure generated by ventilator would not be transmitted to the pulmonary vessels but rather to the atmosphere. So, the purpose of this study is to evaluate the ability of SVV as an indicator a fluid responsiveness particularly in patients undergoing one-lung ventilation with thoracotomy and to found the optimal threshold value of SVV for fluid management during thoracic surgery.

Eligibility: Inclusion Criteria:
  -  The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital
  Exclusion Criteria:
  -  The patients with known cardiac disease include arrythmia
  -  American society of anesthesia physical status III, IV, V

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Study of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)

Summary: Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC.
  The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.


Eligibility: Inclusion Criteria:
  1. Subjects >/= 18 years and </=70 years of age at the time of Informed Consent.
  2. Advanced relapsed or refractory predominantly NSCLC with documented wild-type EGFR.
  3. At least one measurable lesion according to RECIST 1.1.
  4. Failure of second line of chemotherapy.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  6. Patients must have recovered from any AEs of prior treatments before randamization.
  7. Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALT and AST < 2.5×ULN; TBIL ≤1.25×ULN; Cr ≤1.25×ULN;CL>45 ml/min.
  8. Life expectancy of at least three months.
  9. Written informed consent and the willingness and ability to comply with all aspects of the protocol.
  Exclusion Criteria:
  1. Presence of types of small-cell, squamous-cell, adeno-squamous-cell lung cancer.
  2. Pregnant or breast-feeding women.
  3. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure >/= 140 mm Hg and/or diastolic pressure >/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
  4. Factors to affect oral administration(inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
  5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy>/= CTCAE 2 pneumorrhagia or >/= CTCAE 3 hemorrhage in other organs within 4 weeks.
  6. Bone fracture or wounds that was not cured.
  7. Arterial thrombus or phlebothrombosis within 12 months and taking anticoagulant agents.
  8. Mental diseases and psychotropic substances abuse.
  9. Previous treatment with an trial agent within 4 weeks
  10. Previous treatment with VEGFR,platelet derived growth factor receptor(PDGFR) TKIs.
  11. Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
  12. Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

Summary: This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  Male and female patients age at least 18 years of age, or age of consent in the region.
  -  Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
  -  Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
  -  Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
  Exclusion Criteria:
  -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
  -  Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
  -  Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
  -  Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Summary: This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2.
  -  Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
  -  Has an archived, diagnostic tumor tissue available for analysis.
  -  Has adequate hematologic, renal, cardiac and hepatic function.
  -  Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
  Exclusion Criteria:
  -  Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
  -  Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
  -  History of major immunologic reaction to any IgG containing agent.
  -  Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Characterization of Methylation Patterns in Lung Cancer

Summary: In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Detailed description: Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Eligibility: Inclusion Criteria:
  -  Patients with suspected lung tumor
  Exclusion Criteria:
  -  Patients who have active disease other than lung cancer during the sample collecting

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China

Summary: To understand 286 gene mutation mutation rates (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect) by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Detailed description: This study is prospective to identify biomarkers to resistant to afatinib，gefitinib and erlotinib in non-small cell lung cancer patients. Mutations of whole exon of 286 gene are analysed by deep sequencing in Chinese patients with non-small cell lung cancer and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Eligibility: Inclusion Criteria:
  -  Age>18 years,both male and female
  -  Histologically confirmed patients with pulmonary adenocarcinoma (Stage I-IV)
  -  ECOG 0-2
  -  Patients with enough paraffin tissue specimens or fresh tissue for detection
  -  Quality of the DNA extracted from the tissue samples ensures that the DNA can be used in DNA sequencing or FISH detection
  -  Subjects who provide detailed clinical and follow-up information
  Exclusion Criteria:
  -  Patients with other tumors
  -  Patients suffering from other serious diseases like infectious diseases (viral hepatitis, HIV,etc)
  -  Pregnant women shall be excluded

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

Summary: This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
  -  Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
  -  Presence of at least one measurable lesion as defined by RECIST 1.1
  -  Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
  -  Patient has a WHO performance status 0-1
  Exclusion Criteria:
  -  Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
  -  Patients with an active, known or suspected autoimmune disease
  -  Unable or unwilling to swallow tablets or capsules
  -  Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results

Relevance to patient case: not relevant