araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Anticancer Activity of Nicotinamide on Lung Cancer

Summary: Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer cells. Nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.

Detailed description: The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). To determine the effectiveness of nicotinamide on lung cancer, nicotinamide or placebo tablet will be co-administered with gefitinib or erlotinib for two years until the event or censoring occurs. The stratified block randomization was designed with 3 covariates (EGFR mutation status, kind of EGFR-TKI, ECOG (Eastern Cooperative Oncology Group) performance status score variation). The size of lesions will be checked every other months by radiology. PD (progressive disease) will be assessed according to RECIST(Response Evaluation Criteria in Solid Tumors)1.1. After observing 36 events, an interim analysis of hazard ratio by Cox proportional hazard regression will be performed. The final analysis will be done by the same protocol after observation of 72 events. The significance level of the interim and final analysis were set to 0.0075 and 0.0209 respectively. Response rate, quality of life (measured by 10 questions at every visit), and overall survival will be analysed together. All other adverse reactions will be analysed and reported, if there.

Eligibility: Inclusion Criteria:
  -  Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy
  -  EGFR mutated (exon 19 deletion or L858R mutation)
  -  Life expectation more than 3 months
  -  More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously
  -  ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2
  -  Who signed the informed consent form
  Exclusion Criteria:
  -  Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy
  -  Who has metastasized brain lesion that needs operation or radiation therapy
  -  Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney
  -  Who does Not agree to contraception
  -  Who has allergy to nicotinamide

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC

Summary: This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Detailed description: The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.

Eligibility: Inclusion Criteria:
  -  Current patient at participating clinic
  -  Metastatic breast cancer diagnosis
  -  18 years of age or older
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic NSCLC
  -  EGFR mutation (L858R and /or ex19del)
  -  cMET amplification by FISH (GCN ≥ 6),
  -  Acquired resistance to EGFR TKI (1st or 2nd génération)
  -  ECOG performance status (PS) ≤ 1.
  Exclusion Criteria:
  -  Prior treatment with 3rd generation TKI
  -  PhaseII : Prior treatment with any of the following agents:
  -  Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.
  -  Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.
  -  Platinum-based chemotherapy as first line treatment

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

Summary: This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.

Detailed description: This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC.
  After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:
  -  Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
  -  Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).
  Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks.
  The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.

Eligibility: Inclusion Criteria:
  Histological or cytological diagnosis of NSCLC;
  -  Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
  -  Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
  -  Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice;
  -  No prior treatment for NSCLC is allowed;
  -  Adequate tissue in terms of quality and quantity for EGFR local testing.
  Exclusion Criteria:
  -  no adequate bone marrow function within 2 weeks prior to randomization
  -  no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
  -  no adequate renal function within 2 weeks prior to randomization
  -  known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
  -  known history of allergic reactions attributed to compounds of similar chemical or biological composition;
  -  history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Functional Status in Patients Undergoing Curative Treatment for Lung Cancer

Summary: This trial investigates the impact of curative lung cancer treatment on functional status and exercise tolerance. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.

Detailed description: Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 70 patients with lung cancer who are treated curatively. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy). The aims of the study are to
  1. Investigate the influence of curative treatment for lung cancer on functional and maximal exercise tolerance (primary outcome).
  2. Investigate the metabolic changes underlying changes in exercise tolerance during curative treatment for lung cancer (primary outcome).
  3. Investigate the relationship between changes in exercise tolerance, daily physical activity, pulmonary function and skeletal muscle function during curative treatment for lung cancer (secondary outcome).
  4. Investigate the relationship between changes in exercise tolerance and self-reported quality of life, functional status, feelings of anxiety and depression and symptoms during curative treatment for lung cancer (secondary outcome).
  5. Investigate the relationship between physical activity and exercise tolerance on one hand and comorbidities, hospitalisations and cancer-related and all-cause mortality on the other hand after curative treatment for lung cancer (exploratory outcome).

Eligibility: Inclusion Criteria:
  -  curative treatment for lung cancer
  Exclusion Criteria:
  -  presence of other neoplasms
  -  progressive neuromuscular and neurological diseases
  -  unstable cardiac disease
  -  pulmonary hypertension
  -  interstitial lung disease
  -  orthopedic conditions that significantly impair functional status
  -  mental or psychiatric disorders that impair the ability to comply with study procedures.
  -  a history of cerebrovascular accident with remaining functional consequences
  -  a history of lung cancer
  -  lack of knowledge of the Dutch, French or English language will be excluded

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease

Summary: The investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD), and COPD were identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.

Detailed description: The epidemiology of lung cancer related to interstitial lung disease (ILD) with or without with connective tissue disease (CTD) as well as idiopathic pulmonary fibrosis (IPF) has not been well established yet. Interstitial lung disease has a potential to develop lung cancer in the name of scar cancer. The investigators aimed to explore prevalence of lung cancer in patients with ILD with or without CTD and IPF in comparison with chronic obstructive pulmonary disorder (COPD).
  The investigators will evaluate the prevalence of lung cancer associated with ILD and IPF utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. The sample cases are total 1,375,842. Among them 670,258 cases (age > 40) were evaluated. Patients with ILDs, IPF, CTD, and COPD will be identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.

Eligibility: Inclusion Criteria:
  -  equal to above 40 years old
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Tumor-specific T Cells in Lung Cancer

Summary: Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)
  -  Healthy donors (control group)
  -  written informed consent
  Exclusion Criteria:
  -  Autoimmune disease
  -  Patients receiving immunomodulatory drugs, e.g. tacrolimus
  -  Prior malignancy
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Summary: Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.

Detailed description: Investigators invited participants with family history to join in this study under the criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; (3) compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. The participants with (1) proved lung cancer either with or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3) any other cancer history or (4) chest CT examination within one year would be excluded from the study.
  The study was planned to enroll 1000 participants from simplex families and 500 participants from multiplex families for lung LDCT screening. Multiplex family was defined as two or more family members with lung cancers, and simplex family as one family member with lung cancer.

Eligibility: Inclusion Criteria:
  1. relatives of the lung cancer patients;
  2. age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;
  3. compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.
  Exclusion Criteria:
  1. proved lung cancer either with or without treatment,
  2. presence of hemoptysis or history of remarkable lung fibrosis,
  3. any other cancer history or
  4. chest CT examination within one year

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Summary: Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR might be important role in salivary gland cancers. Accordingly, several trials with various anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in salivary gland cancer are ongoing.
  Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg, leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of a broad range of differing human tumors.
  Based on this background, in this study, the investigators would like to conduct a phase II study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland cancer of the head and neck to evaluate efficacy and safety.


Eligibility: Inclusion Criteria:
  -  Histologically proven salivary gland cancer of the head and neck (According to WHO classification, mucoepidermoid cancer, adenoid cystic carcinoma, or adenocarcinoma/salivary duct cancer are eligible)
  -  Recurrent or metastatic salivary gland cancer of the head and neck patients who failed one line of systemic chemotherapy
  -  age ≥ 18 years
  -  At least one measurable tumor lesion according to RECIST 1.1
  -  ECOG performance status 0-2
  -  Adequate hematologic function (absolute neutrophil count > 1,500/m/, platelets > 100,000/ml, haemoglobin > 9.0 g/dl), hepatic function (alanine transaminase/aspartate transaminase < 5 x ULN, total bilirubin < 1.5 x ULN), renal function (creatinine clearance > 45 ml/min)
  -  Written informed consent
  Exclusion Criteria:
  -  Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment, or arrhythmia
  -  Hemorrhagic or thromboembolic events in the past 6 months
  -  Major injuries in the 10 days prior to start of the study
  -  Patients with post-obstructive pneumonia or uncontrolled serious infection
  -  Pregnant or nursing women
  -  Uncontrolled symptomatic brain metastasis
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, and well treated thyroid cancer

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

Summary: This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

Detailed description: This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
  All patients received five cycles of weekly docetaxel and cisplatin, each of 1 day's duration. Thoracic RT includes the delivery of 65 Gy in 25 fractions on weekdays for a total of five weeks.
  Nimotuzumab group was treated with five doses of weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while placebo group was treated with five doses of placebos.
  150 patients are needed to be enrolled for an 80% power to detect an improvement in overall survival from 15 months to 25 months.

Eligibility: Inclusion Criteria:
  -  histologically confirmed squamous cell lung cancer
  -  patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  -  unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI
  -  ECOG performance status 0-1
  -  Previously treated with chemotherapy or treatment-naive
  -  no previous chest radiotherapy, immunotherapy or biotherapy.
  -  hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
  -  serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
  -  bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
  -  FEV1 >0.8 L
  -  CB6 within normal limits
  -  patients and their family signed the informed consents
  Exclusion Criteria:
  -  adenosquamous carcinoma
  -  previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
  -  contraindication for chemotherapy
  -  women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
  -  women who has the probability of pregnancy without contraception
  -  tendency of hemorrhage
  -  in other clinical trials within 30 days
  -  addicted in drugs or alcohol, AIDS patients
  -  uncontrollable seizure or psychotic patients without self-control ability
  -  severe allergy or idiosyncrasy
  -  not suitable for this study judged by researchers

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

Summary: This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

Detailed description: GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.

Eligibility: Inclusion Criteria:
  -  lung cancer and breast cancer patients confirmed by surgery pathology;
  -  ECOG physical stamina score of 0~3 points;
  -  Expected lifetime > 3 months;
  -  Need to receive radiation and chemotherapy;
  -  Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
  -  To follow-up, good adherence
  Exclusion Criteria:
  -  Allergic to text drug;
  -  Pregnancy or lactation women;
  -  Suffering from mental illness of not easy to control,
  -  Have serious mental or cognitive dysfunction;
  -  Can not comply with the experimental scheme or can't cooperate with the follow-up;
  -  The patients who are unfavorable to the subject.

Relevance to patient case: not relevant