araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

Summary: The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.

Detailed description: The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.
  In addition, the overall survival and safety index will be collected for analyses.

Eligibility: Inclusion Criteria:
  1. Patients had to voluntarily join the study and give written informed consent for the study;
  2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);
  3. A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)
  4. Sensitive EGFR mutations (19del, 21L858R);
  5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
  6. Patients did not receive systemic anti-cancer therapy previously;
  7. Able to comply with study and follow-up procedures;
  8. Age >= 18 years, ECOG PS: 0-1, estimated survival duration more than 3 months;
  Exclusion Criteria:
  1. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);
  2. Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;
  3. EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;
  4. Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)];
  5. Symptomatic or untreated brain metastases;
  6. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible);
  7. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications;
  8. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption;
  9. Pregnancy or lactation.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma

Summary: In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.
  Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.
  The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  stage I lung adenocarcinoma
  Exclusion Criteria:
  -  cases with any new adjuvant treatment prior to surgery

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

Summary: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Detailed description: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.
  Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma positive EBUS-TBNA specimen
  Exclusion Criteria:
  -  other diagnosis

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

Summary: In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.

Detailed description: This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date.
  The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.

Eligibility: Inclusion Criteria:
  1. lung adenocarcinoma, stage IV
  2. Patients with HER2 mutation by sequencing
  - Confirmed triple-negative patients with remnant tumor DNA
  3. Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
  4. ECOG performance status 0~2
  5. Patient with at least one measurable lesions according to RECIST
  6. Patients who have proper organ functions as follows
  -  Neutrophil count: > 1,500/uL
  -  Platelet count: > 100,000/uL
  -  Hb: > 9.0g/dL
  -  AST/ALT : < 2.0 x upper normal limit
  -  Bilirubin: < 1.25 x upper normal limit
  -  Serum creatinine : < upper normal limit
  Exclusion Criteria:
  1. Expected lie expectancy < 3 months
  2. CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
  3. Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  4. Patients who have histories of previous exposure to EGFR-TKI

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China

Summary: The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.

Detailed description: In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion

Eligibility: Inclusion Criteria:
  -  NSCLC adenocarcinoma patients confirmed by pathologist
  -  Initial, non-operative patients with stage III & IV adenocarcinoma
  -  Older than 18 years old
  -  Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.
  PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;
  -  Have a clear measurable tumor lesion in lung,under RIEST.
  -  Without severe drug allergy
  -  Patients participate in this trail must sign the informed consent
  Exclusion Criteria:
  -  Patients with brain metases related syndrome
  -  Patients with bone metases related complication
  -  Patients with cognitive disorder
  -  Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
  -  Patients with other severe complication and excluded by the researcher.
  -  Patients who are allergy with the TKI in this trail.
  -  Patients who participated in other trails or with anti-tumor treatments
  -  Patients who receive radiotherapy at the site of curative effect observation
  -  Patients who receive allogenic blood transfusion within 14 days

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis

Summary: This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

Detailed description: This study planned to enroll 50 patients with lung cancer diagnosed with brain (meningeal) metastases, and all cases were slated to receive radiotherapy and targeted therapy. Patients' clinical data were collected (including but not limited to: age at diagnosis with brain (meningeal) metastases, KPS score, smoking history, stage of disease at diagnosis, time to progress to brain metastases, number of brain metastases, extracranial metastases (ECM), and systemic disease at the time of brain metastases. Anticoagulated whole blood and anticoagulated cerebrospinal fluid were collected before local treatment (samples of primary cancer tissue and metastatic carcinoma of some patients were preserved) and at 7 days, 1 month, 3 months, as well as 6 months after the treatment (time of sample retention was to be determined, Figure 2). DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid, for complete quantitative detection of DNA, DNA library construction, as well as targeted capture sequencing. Tumor-related genes were analyzed, and changes in the tumor burden during the treatment process were evaluated. The clinical significance of cfDNA in the plasma and cerebrospinal fluid for treatment efficacy and prognosis was evaluated, and compared with that of clinical indicators of treatment efficacy.
  This study involved two stages. The first stage was a pre-experiment: samples were retained from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and cerebrospinal fluid were compared. The investigators analyzed, combined with clinical indicators, whether mutations of cfDNA in plasma accord with that of the cerebrospinal fluid and whether mutations of cfDNA in cerebrospinal can reflect the mutational status of tumor cells. The second phase was conducted by expanding the number of cases, based on the first stage.

Eligibility: Inclusion Criteria:
  1. Patients with confirmed diagnosis of lung adenocarcinoma with brain (meningeal) metastasis.
  2. Samples collection should be allowed.
  Exclusion Criteria:
  1. Pregnant women
  2. Minors (subjects less than 18 years of age)

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project

Summary: This is a group randomized trial of an intervention to improve chronic illness self-management.


Eligibility: Inclusion Criteria:
  -  ≥ 25 years
  -  AI
  -  diagnosed with diabetes
  -  hypertension
  -  osteoporosis
  -  liver disease
  -  chronic lung disease (asthma, chronic bronchitis or emphysema)
  -  heart disease (coronary artery disease or congestive heart failure)
  -  stroke (completed cerebrovascular accident with neurologic handicap and normal mentation)
  -  chronic arthritis
  Exclusion Criteria:
  -  major medical illness that precludes their attendance at 7 meetings
  -  <25 years of age

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR TKI Therapy

Summary: A comparison of baseline tumor characteristics in EGFR mutant lung cancers to tumor characteristics after early response of EGFR-TKI targeted treatment to allow identification of early adaptive mechanisms of cell survival in the setting of oncogene-targeted therapy. This identification will facilitate targeting and termination of these survival/resistance pathways before they develop with rational combination of therapeutic agents to improve outcomes.


Eligibility: Inclusion Criteria:
  -  Carry a diagnosis of stage IV lung adenocarcinoma with an EGFR activating mutation
  -  Aged 18 - 85 years or older
  -  ECOG 0-2
  -  Have a histologically confirmed diagnosis of lung adenocarcinoma harboring an EGFR sensitizing mutation (including, but not limited to: G719X, del exon 19, or L858R).
  -  No prior therapy for metastatic disease.
  -  Planned treatment with a single agent EGFR TKI including but not limited to:
  1. erlotinib,
  2. gefitinib,
  3. rociletinib (CO-1686),
  4. afatinib, or
  5. osimertinib (AZD-9291).
  -  Patients must have at least one site of measurable disease ≥ least 2cm.
  -  Primary disease site or site of metastatic disease must be amenable to biopsy.
  -  Patients must have the ability to understand and willingness to sign an informed consent document.
  -  Patients must be willing to undergo an initial pre-treatment biopsy of tumor tissue (or have previously collected frozen tissue) and a follow-up biopsy 2 weeks (+/- 1 week) after treatment start
  Exclusion Criteria:
  -  Concurrent health problem which would preclude tissue biopsy (eg hemophilia or other bleeding predisposition).
  -  Patients whose only source of biopsiable disease is:
  1. intracranial,
  2. pleural effusion or any lesion that is deemed unsafe to biopsy by the treating physician or,
  3. interventional radiology.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Summary: To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

Detailed description: In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
  -  ECOG performance status 0-2 with expected more than 6 months of survival time
  -  Willingness to comply with required protocols and give permission to use the data for clinical research and products development
  Exclusion Criteria:
  -  Patients have other primary cancers
  -  Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
  -  Patients failed in either plasma or tissue sample QC

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Summary: The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.


Eligibility: Inclusion Criteria:
  -  Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at MSKCC
  -  Somatic activating mutation in EGFR Radiographic progression during treatment with erlotinib.
  -  Any number of prior chemotherapy regimens is permitted.
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated
  -  KPS >/= 70%
  -  Age >18 years old
  -  Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of > 10 unstained slides)
  -  Left ventricular Ejection Fraction >/= the lower limit of normal by ECHO or MUGA
  -  Adequate organ function:
  -  AST, ALT </= 2.5 x ULN
  -  Total bilirubin </= 1.5 x ULN
  -  Albumin>/=2.6g/dL - Creatinine < 1.5 x ULN OR calculated creatinine clearance >/=50mL/min
  -  Absolute neutrophil count (ANC) >/= 1,200 cells/mm3
  -  Hemoglobin>/=9.0 g/dL
  -  Platelets >/=100,000/mm3
  Exclusion Criteria:
  -  Patients with symptomatic brain metastasis requiring escalating doses of steroids
  -  Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption
  -  Pregnant or lactating women
  -  Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a EGFR TKI
  -  Patients who have received prior treatment with a MEK inhibitor
  -  Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol.
  -  A history of clinically significant interstitial lung disease or pneumonitis
  -  Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic uncontrolled Arrythmias, prolonged corrected QT interval >480msec, treatment refractory hypertension, presence of a cardiac defibrillator
  -  History of central serous retinopathy or retinal vein occlusion

Relevance to patient case: not relevant