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

Clinical trial: Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-04/ECHO-305-04)

Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation.
  -  Measurable disease based on RECIST 1.1.
  -  Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score [TPS] ≥ 50%) as assessed by immunohistochemistry at a central laboratory.
  -  Life expectancy of at least 3 months.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate organ function per protocol-defined criteria.
  Exclusion Criteria:
  -  Known untreated central nervous system metastases and/or carcinomatous meningitis.
  -  History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  -  Symptomatic ascites or pleural effusion.
  -  Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  -  Active autoimmune disease that has required systemic treatment in past 2 years.
  -  Has had an allogeneic tissue/solid organ transplant.
  -  Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  -  Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  -  History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  -  Use of protocol-defined prior/concomitant therapy.

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

Clinical trial: Randomized Phase 2 Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)

Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
  -  Measurable disease based on RECIST 1.1
  -  Life expectancy of at least 3 months.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate organ function per protocol-defined criteria.
  -  Provide tumor tissue sample.
  Exclusion Criteria:
  -  Known untreated central nervous system metastases and/or carcinomatous meningitis
  -  History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  -  Symptomatic ascites or pleural effusion.
  -  Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  -  Active autoimmune disease that has required systemic treatment in past 2 years.
  -  Has had an allogeneic tissue/solid organ transplant.
  -  Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  -  Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  -  History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  -  Use of protocol-defined prior/concomitant therapy.

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

Clinical trial: Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity

Summary: The purpose of this study is to evaluate the impact of systematic sampling of lymph nodes vs. lymphadenectomy on outcome according to intraoperative frozen pathology for pulmonary invasive adenocarcinoma with ground-glass opacity (GGO) after VATS lobectomy.

Detailed description: On HRCT screening, early lung adenocarcinoma often contains a nonsolid component called ground-glass opacity (GGO). In 2011, pulmonary adenocarcinomas were classified into atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), minimally invasive carcinoma (MIA) and more extensively invasive adenocarcinoma (IAC) [1]. Early adenocarcinomas with GGO-dominant always mean low-grade malignancy and have an extremely favorable prognosis [2-5]. Previous studies have shown that patients with AAH, AIS and MIA have excellent survival rates (5-year survival rate is approximate 95%) after resection, and only 0.83% - 2.91% patients have lymph node metastasis [6-9]. At present, lymphadenectomy is always undergone in patients with pulmonary adenocarcinoma with ground-glass opacity. However, for MIA patients (especially in T1a-b stage), the appropriate use of lymphadenectomy continues to be debated.
  Nowadays, intraoperative frozen pathology is widely used during operation. However, whether sampling of lymph nodes or lymphadenectomy should be performed for GGO lesions according to intraoperative pathological diagnosis is unclear. The aim of this prospective study is to evaluate whether there are any trends regarding the impact of subtypes of invasive adenocarcinoma according to intraoperative frozen pathology in sampling of lymph nodes vs. lymphadenectomy.

Eligibility: Inclusion Criteria:
  1. A peripheral nodular lesion;
  2. The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
  3. VATS lobectomy
  4. 25%≦Consolidation/Tumor ratio ≦50%
  5. ECOG performance status 0-2;
  6. Without distant metastasis;
  7. Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.
  8. No operation contraindication
  9. Cardiovascular: Cardiac function normal
  10. Renal: Creatinine clearance greater than 60 ml/min
  11. The expected survival after surgery ≥ 6 months
  12. Must be able to sign written informed consent form
  Exclusion Criteria:
  1. Age less than 18 years old
  2. Known hereditary bleeding disorder with history of post-operative hemorrhage
  3. Patients maintained on chronic anticoagulation (eg Coumadin therapy)
  4. Known hematogenous disorder
  5. Known primary or secondary malignancy
  6. Pregnant or breast-feeding women;
  7. Clinically significant heart disease;
  8. Patients who are unwilling or unable to comply with study procedures;
  9. Receiving immunosuppressive therapy;
  10. HIV/AIDS.
  11. Multiple lesions in lung

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

Clinical trial: Safety and Efficacy of Xalkori ROS1

Summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.


Eligibility: Inclusion Criteria:
  -  patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive
  Exclusion Criteria:
  -  Patients with past history of hypersensitivity to any of the ingredients of XALKORI

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

Clinical trial: Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

Summary: This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy

Detailed description: This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).
  First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.
  The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

Eligibility: Inclusion Criteria:
  1. Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.
  • Either primary biopsy or repeated biopsy
  2. Age 18-90.
  3. PI-RADS classification of 3-5
  Exclusion Criteria:
  1. Men who do not have an MRI of the prostate.
  2. PI-RADS classification of 2 or lower
  3. Men who were diagnosed with prostate cancer and have begun treatment

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

Clinical trial: An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

Summary: This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology
  -  Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)
  -  No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease
  -  Participants must have biomarker test results available for randomization
  -  ECOG Performance Status of ≤ 1
  -  Measurable disease by CT or MRI per RECIST 1.1 criteria
  Exclusion Criteria:
  -  Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements
  -  Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  -  Participants with an active, known or suspected autoimmune disease [Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]
  -  Participants with untreated CNS metastases are excluded [Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment]
  Other protocol defined inclusion/exclusion criteria could apply

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

Clinical trial: Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

Summary: This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in combination with standard platinum-based chemotherapy in subjects with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Subjects with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., subjects with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.) Subjects with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.


Eligibility: Inclusion Criteria:
  1. Male or female, aged 18-75 years on the day of signing informed consent.
  2. Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
  Note: Subjects with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
  3. Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
  4. Subjects must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
  Exclusion Criteria:
  1. Subjects with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for subjects with non- squamous NSCLC). Subjects with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
  2. Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
  3. Prior therapies targeting PD-1, PD-L1 or PD-L2

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

Clinical trial: Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Summary: This is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes.
  Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm.
  This study consists of two Periods for Enrolled subjects:
  -  Treatment Period - subjects will receive up to 12 months of treatment.
  -  Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.


Eligibility: Inclusion Criteria:
  -  Completely resected histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)]
  -  V600E/K mutation positive using a validated local test
  -  Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
  -  Subjects who have previously had Stage III melanoma at any time are not eligible.
  -  Subjects with an unknown primary melanoma are not eligible.
  -  Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  Exclusion Criteria:
  -  Uveal or mucosal melanoma
  -  Evidence of metastatic disease including unresectable in-transit metastasis
  -  Received any prior adjuvant or neoadjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
  -  Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ
  -  History or current evidence of cardiovascular risk
  -  A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy

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

Clinical trial: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Summary: Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years of age
  -  Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
  -  Stage IV disease
  -  Sufficient FFPE tumour tissue for OCCP testing
  -  Performance status 0-2
  -  Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
  -  Prognosis > 6 months
  -  Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed
  Exclusion Criteria:
  ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy

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

Clinical trial: Noninvasive vs. Invasive Lung Evaluation

Summary: Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Patients with NSCLC, which is: (1) Biopsy-proven (confirmatory biopsy must have been collected within 12 months prior to enrollment), (2) Metastatic (Stage IV, Stage IIIB when curative intent is not an option, or relapsed/recurrent disease after original diagnosis of Stage I-IIIA), (3) Non-squamous histology (mixed squamous and adenocarcinoma is allowed), (4) No prior treatment for advanced stage NSCLC: (a) Resection of or radiation to a single metastatic site is allowed if there are other untreated and measurable sites of metastatic disease at the time of enrollment. (b) Patients who have previously undergone surgical resection or radiation for Stage I-IIIA NSCLC are eligible if primary treatment was completed at least 6 months prior to the development of metastatic disease; for patients who received adjuvant systemic therapy, the last dose of treatment must be given at least 6 weeks prior to enrollment.
  -  Age ≥ 18 years
  -  Ability to understand a written informed consent document, and the willingness to sign it.
  -  Willingness to provide blood sample at the time points of pre-treatment, approximately 2 weeks after initiation of systemic treatment, and end of study).
  -  Patient has or will have standard-of-care tissue genotyping ordered. If the physician intends to order tissue genotyping, but there is insufficient material for analysis, the patient is still eligible for enrollment.
  Exclusion Criteria:
  -  Pregnancy
  -  Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease.
  -  Prior treatment for metastatic NSCLC including but not limited to: (1) Systemic treatment (targeted therapy, chemotherapy, immunotherapy, biologic therapy, etc.), (2) Resection of a metastatic lesion if the resected metastasis had been the only site of measurable metastatic disease, or resection of more than one metastatic lesion, (3) Radiation of a metastatic lesion or resection bed if given to the only measurable site of metastatic disease, or radiation to more than one metastatic lesion.

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

Clinical trial: HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Summary: The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.

Detailed description: This observational study will serve to collect data from medical record review and questionnaires before and after High Intensity Focused Ultrasound (HIFU) for focal ablation of prostate tissue. The subject will have already undergone or opted to receive the HIFU procedure as part of standard of care in order to participate in this study.

Eligibility: Inclusion Criteria:
  1. Age 40 years to 85 years
  2. Subject has elected or already undergone HIFU therapy as their standard of care treatment methodand declined alternative treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
  3. PSA ≤ 20
  4. Prostate volume of ≤ 70 cc
  5. Ability to complete informed consent form
  Exclusion Criteria:
  1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
  2. Medical contraindication to follow-up mpMRI or prostate biopsy
  3. Unable to tolerate general or regional anesthesia
  4. Positive bone scan (only if bone scan has been done or clinically indicated. Bone scan does not need to be performed for study eligibility determination.)

Relevance to patient case: not relevant