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

Clinical trial: Adaptive Planning in Bladder Cancer

Summary: To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater accuracy using a new planning method and that this method can be used simply and effectively by those delivering treatment.

Detailed description: This study integrates a novel adaptive planning methodology, Adaptive-Planning Organ LOcalisation (A-POLO), with optimised margins and cone beam CT technology for improving the accuracy of radiotherapy treatment delivery.
  The previous study (CCR2873, REC 07/Q0801/13) evaluated the use of cone beam CT in radiotherapy for bladder cancer. A larger than expected number of bladder radiotherapy treatments were seen to have been delivered with some element of geographic miss. Using the novel adaptive planning method these fractions of radiotherapy could have been correctly treated. The feasibility of this method has been proven in the previous study, particularly it has been shown that this method is appropriate and provides a simple solution to the problem. It can be carried out by the radiographers at the treatment unit without adding extra time to the treatment.

Eligibility: Inclusion Criteria:
  -  Age > 18
  -  Histologically confirmed invasive carcinoma of the bladder
  -  Patient planned to receive hypofractionated radiotherapy to the bladder.
  -  No previous pelvic radiotherapy
  -  Written informed consent given according to ICH/GCP and national/local regulations.
  Exclusion Criteria:
  -  Urinary catheter in situ: the presence of a urinary catheter degrades cone beam image quality and thus images would not be evaluable. Patients with a urinary catheter would not be expected to show variation in bladder filling.

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

Clinical trial: A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]

Summary: To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.


Eligibility: Inclusion criteria:
  1. Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC]
  2. Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
  3. A known wild-type EGFR status
  4. Patients 18 years of age or older
  Exclusion criteria:
  1. More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
  2. Prior treatment with EGFR targeting small molecules or antibodies
  3. Radiotherapy or surgery within 4 weeks prior to study entry
  4. Active brain metastasis
  5. Known pre-existing interstitial lung disease
  6. History or presence of clinically relevant cardiovascular abnormalities
  7. Cardiac left ventricular function with resting ejection fraction of less than 50%
  8. Absolute neutrophil count[ANC] < 1,500/mm3
  9. Platelet count <100,000/mm3
  10. Creatinine clearance<60ml/min or serum creatinine >1.5 times upper limit of normal
  11. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
  12. Pregnancy or breast-feeding

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

Clinical trial: Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Summary: This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

Detailed description: PRIMARY OBJECTIVE:
  I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy.
  OUTLINE:
  Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.

Eligibility: Inclusion Criteria:
  Pathological documentation of non-small cell lung cancer Stage IV disease Prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed Patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable Patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy Ability to understand and the willingness to sign a written informed consent document
  Exclusion Criteria:
  Prior palliative chemotherapy Pregnant and/or lactating women Prior radiation therapy other than brain irradiation for brain metastases

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 Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor

Summary: MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.


Eligibility: Inclusion Criteria:
  -  Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
  -  Documented positive BRAF mutation (V600E, V600K, or V600D).
  -  Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment.
  -  The subject must have a radiographically measurable tumor.
  -  The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
  -  Able to swallow and retain oral medication.
  -  Sexually active subjects must use acceptable methods of contraception during the course of the study.
  -  Adequate organ system function and blood cell counts.
  Exclusion Criteria:
  -  The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study.
  -  Previous treatment with a MEK inhibitor.
  -  Current use of a prohibited medication listed in the protocol.
  -  Uncontrolled glaucoma.
  -  Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment.
  -  Current severe or uncontrolled systemic disease.
  -  History of clinically significant heart, lung, or eye/vision problems.
  -  Significant unresolved side effects from previous anti-cancer therapy.
  -  The subject is pregnant or breastfeeding.

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 the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

Summary: This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.


Eligibility: Inclusion Criteria:
  -  Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
  -  Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST)
  -  Life expectancy ≥12 weeks
  Exclusion Criteria:
  -  Less than 4 weeks since the last anti‑tumor therapy
  -  Patients receiving erythropoietin products
  -  Active infection requiring antibiotics
  -  Active autoimmune disease that is not controlled by nonsteroidal anti‑inflammatory drugs
  -  Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
  -  Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  -  Known human immunodeficiency virus infection
  -  Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases

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

Clinical trial: Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Summary: Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Detailed description: Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Eligibility: Inclusion Criteria:
  -  Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
  -  Tumor EGFR mutation
  -  Presence of measurable disease by RECIST
  -  stage IIIA or IIIB, non-resectable
  -  ECOG performance status 0-2
  -  No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
  -  Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
  Exclusion Criteria:
  -  Carcinoid tumor, small cell carcinoma of lung
  -  Patients with any distant metastasis
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
  -  Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
  -  Women and men of childbearing potential who have no willing of employing adequate contraception
  -  Tumor EGFR wild

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

Clinical trial: First-in-Man, Dose-escalation Trial of c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors

Summary: EMD Serono has closed enrollment into this trial prior to determination of maximum tolerated dose (MTD). EMD Serono has decided not to pursue the development of EMD 1204831 in patients with advanced solid tumors for reasons other than safety.

Detailed description: This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore the safety, tolerability, pharmacokinetics, and clinical activity of an investigational drug, EMD 1204831, in patients with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will receive EMD 1204831 twice a day (BID) during each 21-day cycle until disease progression or unacceptable toxicity.

Eligibility: Inclusion Criteria:
  Main Inclusion Criteria
  1. Histologically or cytologically confirmed solid tumor, either refractory standard therapy or for which no effective standard therapy is available
  2. Measurable or evaluable disease, as defined by RECIST 1.0
  3. Men or women aged ≥ 18 years
  4. ECOG performance status of 0 to 2
  5. Adequate hematological function: Hemoglobin ≥ 9.0 g/dL; Neutrophils > 1.5 x 109/L; Platelets ≥ 100 x 109/L
  6. Adequate liver function: Total bilirubin ≤ 1.5 x ULN; AST/ ALT ≤ 2.5 x ULN
  7. For subjects with liver metastases: Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 5 ULN
  8. Adequate renal function: Serum creatinine < 1.5 x ULN, and/or Calculated creatinine clearance > 60 mL/min
  9. Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade ≤1, except for alopecia
  10. Recovery from any surgical intervention
  11. Subjects enrolling after the MTD has been determined must present specific c-Met alterations (overexpression, amplification, mutation)
  Exclusion Criteria:
  Main Exclusion Criteria
  1. Received chemotherapy, immunotherapy, hormonal therapy (except subjects with prostate cancer), biologic therapy, or any other investigational agent or anticancer therapy within 28 days (or five half-lives for non-cytotoxics, whichever is shorter), of Day 1 of trial treatment (six weeks for nitrosureas or mitomycin C)
  2. Received extensive prior radiotherapy on more than 30% of bone marrow
  3. Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptics and requiring high doses of steroids
  4. Medical history of liver fibrosis/ cirrhosis
  5. Medical history of surgery within six weeks prior to enrollment
  6. Neuropathy Grade ≥ 2
  7. Requires concurrent treatment with a non-permitted drug
  8. Absence or abnormal pupillary reflex

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

Clinical trial: A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

Summary: Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. This study combines a second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order to overcome resistance and treat this disease.


Eligibility: Inclusion Criteria:
  -  advanced non small cell lung cancer (dose escalation phase)
  -  acquired resistance to erlotinib or gefitinib (expansion phase)
  -  mandatory entrance biopsy (expansion phase)
  Exclusion Criteria:
  -  interstitial lung disease
  -  unstable brain metastases
  -  leptomeningeal disease

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

Clinical trial: Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers

Summary: Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors.
  Exclusion Criteria:
  -  non

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

Clinical trial: Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)

Summary: Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable, non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still controversial. The purpose of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL) and progression-free survival (PFS).

Detailed description: Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.

Eligibility: Inclusion Criteria:
  -  Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
  -  Presence of measurable disease by RECIST
  -  stage IIIA or IIIB, non-resectable
  -  ECOG performance status 0-1
  -  No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy .Patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.
  Exclusion Criteria:
  -  Carcinoid tumor, small cell carcinoma of lung
  -  Patients with any distant metastasis
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
  -  Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
  -  Women and men of childbearing potential who have no willing of employing adequate contraception Tumor EGFR wild

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

Clinical trial: Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

Summary: RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
  PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer

Detailed description: OBJECTIVES:
  Primary
  Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
  Secondary
  Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.
  Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.
  After completion of study therapy, patients are followed up periodically.

Eligibility: Inclusion Criteria:
  1. Patients were required to have histologically or cytologically documented
  2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
  3. No previous history of radiotherapy and surgery of brain
  4. good response( CR/PR) to Erlotinib or Gefitinib.
  5. Agree to radiotherapy
  6. age > 18 and <75 years,ECOG performance status 1 or less
  7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
  8. Have provided informed consent
  Exclusion Criteria:
  1. Seizure cannot be controled by the drugs
  2. Combined with other disease of the brain such as tumour or infarction
  3. Hypersensitivity to MR enhancer -

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

Clinical trial: Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Summary: Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed description: Non small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  -  Metastatic disease treated with gefitinib or erlotinib
  -  Presence of at least one measurable lesion according to RECIST criteria
  Exclusion Criteria:
  -  No tumor tissue available
  -  No clinical data available

Relevance to patient case: not relevant