araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

Summary: This primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies for whom no effective standard treatment is available.


Eligibility: Inclusion Criteria:
  Diagnosis of locally advanced or metastatic cancer that has progressed despite standard therapy or for which no effective standard therapy exists and histological confirmation of one of the following diseases indicated below:
  Single Agent Dose escalation part:documented B-RAF mutant colorectal cancer or pancreatic adenocarcinoma. In addition, tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway are eligible with prior agreement with Novartis.
  Single Agent Dose expansion part: documented B-RAF mutant colorectal cancer with documented RNF43 mutation and/or RSPO fusion or pancreatic adenocarcinoma with documented RNF43 mutation. In addition, patients with tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway (e.g. RNF43 or RSPO fusion) are eligible with prior agreement with Novartis
  LGK974 with PDR001: Dose escalation: patients with the following cancers that were previously treated with anti-PD-1 therapy and whose best response on that therapy was progressive disease (i.e. primary refractory): melanoma, lung SCC, HNSCC. Patients with esophageal SCC, cervical SCC or TNBC who are either naïve or primary refractory to prior anti-PD-1 therapy.
  LGK974 with PDR001: Dose expansion: patients with pancreatic cancer, or TNBC, or melanoma, or head and neck cancer.
  Exclusion Criteria:
  -  Impaired cardiac function
  -  Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral LGK974 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
  -  Brain metastases that have not been adequately treated
  -  Malignant disease other than that being treated in this study
  -  Laboratory abnormalities as specified in the protocol
  -  Osteoporosis, severe or untreated osteopenia
  -  Bone fractures within the past year
  -  Pathologic bone fracture
  -  Active, known or suspected autoimmune disease or severe hypersensitivity reactions to other monoclonal antibodies
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Protein Expression in Samples From Young Patients With Rhabdomyosarcoma

Summary: RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
  PURPOSE: This research trial studies protein expression in samples from young patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:
  -  To measure the protein expression of candidate proteins in human rhabdomyosarcoma (RMS) tumor samples.
  OUTLINE: Archived tumor tissue samples are analyzed for protein expression (i.e., Notch1, Hey1, FGFR4, and Sp1) by IHC techniques and standard commercially available antibodies. Candidate proteins are then correlated with each patient age, gender, rhabdomyosarcoma (RMS) tumor stage, and RMS tumor subtype.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tumor tissue samples from children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials
  -  Alveolar rhabdomyosarcoma (ARMS)
  -  Embryonal rhabdomyosarcoma (ERMS)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Summary: The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Detailed description: Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Eligibility: Inclusion Criteria:
  1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
  2. 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
  4. Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
  5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
  6. Total bilirubin 1.5 x upper limit of normal (ULN)
  7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
  9. If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.
  Exclusion Criteria:
  1. Mixed non-adenocarcinoma cell lung cancer histology
  2. Previous treatment with pemetrexed or tarceva
  3. Be allergic to pemetrexed or tarceva

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)

Summary: Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.

Detailed description: Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.
  FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with >15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning.
  The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population.
  Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

Eligibility: Inclusion Criteria:
  -  The only inclusion criterion was the availability of tissue for biomarker studies.
  Exclusion Criteria:
  -  Disease Progression

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

Summary: A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).


Eligibility: Key Inclusion criteria:
  -  Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carried an ALK rearrangement, as per the FDA-approved Vysis ALK break-apart FISH assay (Abbott Molecular Inc.)
  -  Age 18 years or older at the time of informed consent.
  -  Patients must have NSCLC that had progressed during or after the last chemotherapy regimen received prior to the first dose of LDK378, if chemotherapy was received
  -  Patients must have been chemotherapy-naive or had received 1-3 lines of cytotoxic chemotherapy to treat their locally advanced or metastatic NSCLC
  -  Patients must have had a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
  -  Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who were not allowed to participate in the study.
  Key Exclusion criteria:
  -  Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
  -  Patients with known hypersensitivity to any of the excipients of LDK378.
  -  Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  History of carcinomatous meningitis.
  -  Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
  -  Clinically significant, uncontrolled heart disease.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

Summary: The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Detailed description: This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Eligibility: Inclusion Criteria:
  -  Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  -  Positive EGFR Mutation.
  -  No previous systemic anticancer therapy.
  -  Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  -  Provision of written informed consent.
  Exclusion Criteria:
  -  Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  -  Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product.
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Summary: This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.


Eligibility: Inclusion Criteria:
  -  Adult participants, >/= 18 years of age
  -  Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Adequate hematologic, renal and liver function
  -  Participant initiating treatment with Tarceva according to the Summary of Product Characteristics
  Exclusion Criteria:
  -  Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
  -  Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
  -  Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

Summary: The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.
  Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.
  In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility: Inclusion Criteria:
  -  Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
  -  Available histopathological diagnosis of the malignancy.
  Exclusion Criteria:
  -  Patients with inoperable tumors.
  -  Patients with second primary tumor.
  -  Patients with pathological blocks not enough for future slicing.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Summary: To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
  -  treatment-naïve or have received no more than 3 systemic treatment regimen(s)
  -  Positive for translocation or inversion events involving the ROS1 gene
  -  Negative for translocation or inversion events involving the ALK gene
  -  Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
  -  Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
  -  At least 1 measurable tumor lesion as per RECIST v1.1
  -  Female or male, 18 years of age or older
  -  ECOG performance status 0 to 1
  -  Adequate organ function
  -  Signed and dated informed consent
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
  -  Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial
  -  Prior therapy specifically directed against ALK or ROS1 fusion genes
  -  Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
  -  known interstitial fibrosis or interstitial lung disease
  -  myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
  -  Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec
  -  Pregnant or breast feeding
  -  Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
  -  Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
  -  Evidence of active malignancy within last 3 years

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Treatment of Multifocal Lung Adenocarcinoma

Summary: To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

Detailed description: Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.

Eligibility: -  Patient must be > 18 years of age
  -  Two or more GGO's or solid lesions suspicious for multifocal disease.
  -  Clinical diagnosis of N0
  -  No evidence of distant metastases
  -  No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC).
  -  No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin.
  -  PFT's that show patient is capable of tolerating a lung resection.
  -  Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
  -  Patient must be able to understand and willing to sign an IRB-approved informed consent document.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.

Summary: This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas


Eligibility: Inclusion Criteria:
  -  No previous diagnosis of adenocarcinoma of the prostate
  -  No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
  -  Active urinary tract infection
  Exclusion Criteria:
  -  Prior pelvic radiotherapy
  -  Prior androgen deprivation therapy
  -  Evidence urinary tract infection or significant urinary retention
  -  Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
  -  Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)

Relevance to patient case: not relevant