araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases

Summary: This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.

Detailed description: This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
  All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed NSCLC and wild type EGFR
  -  4-10 brain metastases on high quality CT scanning or MRI.
  -  No previous EGFR-TKI treatment.
  -  No previous brain radiotherapy.
  -  More than 4 weeks from last chemotherapy.
  -  Expected Survival of at least 2 months.
  -  KPS≥ 70
  -  RTOG RPA performance status 0-1
  -  Lab tests should meet these criteria: White blood cell count ≥3×10^9 /L;Platelet count≥100×10^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
  -  Pregnancy test (-)
  -  Be able to sign informed consent form.
  Exclusion Criteria:
  -  With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases)
  -  With metastases on meninges.
  -  Taking antiepileptics (phenytoin sodium etc.) at the same time
  -  Unable to oral medication.
  -  Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

Summary: EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

Detailed description: 1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Eligibility: Inclusion Criteria:
  -  NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.
  Exclusion Criteria:
  -  liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Summary: This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility: Inclusion Criteria:
  -  Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
  -  Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT).
  -  Patients who take EGFR-TKI as first/second line therapy.
  Exclusion Criteria:
  -  Patients who has taken EGFR-TKI before.
  -  Patients who take EGFR-TKI as third or more line.
  -  Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
  -  The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
  -  Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Evaluate EGFR Mutation Status and Impact Factors in North China

Summary: Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.

Detailed description: Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.

Eligibility: Inclusion Criteria:
  -  Histological or cytological confirmed NSCLC;
  -  Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014;
  -  Researchers should collect the records of consecutive NSCLC patients in each site.
  Exclusion Criteria:
  -  Any patients without NSCLC diagnosis;
  -  Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: EGFR Mutations on ctDNA in Patients With Advanced NSCLC

Summary: The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Patient had received ≤ 1 prior systemic chemotherapy regimens;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  Exclusion Criteria:
  -  Prior received ≥2 systemic chemotherapy regimens;
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  -  Histologically confirmed small cell lung cancer or other metastatic tumors;
  -  Patient with no histologic or cytological diagnosis;

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer

Summary: Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and HPV genotyping by reverse hybridization.
  Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal


Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2, not pregnant.
  -  Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
  -  Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy.
  -  Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
  -  Measurable disease (RECIST 1.1).
  -  Adequate hematological values, renal and hepatic function.
  -  Patients may not be receiving any other investigational agents
  Exclusion Criteria:
  -  Platinum-naïve patients.
  -  Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Known or suspected brain metastases.
  -  Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
  -  Known hypersensitivity to panitumumab active ingredient or excipients.
  -  Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - HIV positive patients

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

Summary: This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.


Eligibility: Inclusion Criteria:
  -  Age older than 18 years and under 75 years
  -  Histologically and cytologically proven non-small Cell Lung Cancer
  -  Clinical stages Ⅲ ~ Ⅳ
  -  Not receive any anti-tumor treatment
  -  Eastern cooperative oncology group performance status (ECOG PS) =1~2
  -  Estimated survival time more than 3 months
  -  EGFR-TKI treatment for first-line or second-line
  -  Voluntary to participate in this clinical trial and sign the consent form
  Exclusion Criteria:
  -  Patients have received EGFR-TKI therapy before the study
  -  With other malignancy history in the recent 5 years before the study
  -  Pregnancy or breast feeding phase
  -  Inadequate samples for testing
  -  Follow-up compliance is poor

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)

Summary: In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.
  1. methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
  2. analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.

Detailed description: According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.

Eligibility: Plasma and tissue matching group:
  Inclusion Criteria:
  -  18~80 years old
  -  Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
  -  Did not receive any anti-tumor treatment.
  -  Sufficient samples for analysis
  Exclusion Criteria:
  -  Female patients of childbearing potential who are nursing or are pregnant.
  -  Samples are collected after patients receiving anti-tumor treatment.
  -  The plasma sample hemolysis.
  -  Tumor cells are not found in FFPE samples.
  -  Incomplete information of subjects
  predicting clinical efficacy group:
  Inclusion Criteria:
  -  18~80 years old
  -  Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
  -  At least one measurable focus
  -  With EGFR-TKI treatment
  -  Complete follow-up information after EGFR-TKI treatment
  -  Sufficient samples for analysis
  Exclusion Criteria:
  -  FFPE samples are collected after EGFR-TKI treatment.
  -  Female patients of childbearing potential who are nursing or are pregnant.
  -  Tumor cells are not found in FFPE samples.
  -  Incomplete information of subjects

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Novel Detection System for Lung Cancer Curative Effect Monitoring

Summary: The purpose of this study is to investigate the sensitivity，specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our findings in plasma with survival of advanced patients.

Detailed description: Non-small cell lung cancer (NSCLC), accounting for 80% of all lung cancers, is a leading cause of cancer deaths worldwide. Inhibition of epidermal growth factor receptor (EGFR) kinase activity by EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, can result in improved response and prolonged progression-free survival (PFS) in selected non-small cell lung cancer (NSCLC) patients harboring sensitizing EGFR mutations, especially the exon 19del and exon 21（L858R） mutations. Unfortunately, about 50%-60% patients who accept EGFR tyrosine kinase inhibitors with sensitizing mutations will receive resistance mutations, the T790M resistance is a target of active pharmaceutical development. So EGFR mutation testing is a step in identifying the right patients for EGFR tyrosine kinase inhibitors treatment. Now tissue samples and tumor cytologic samples are accepted as appropriate sample types for EGFR mutation detection, but these samples are not always available on or after diagnosis, and, even when available, they may be of insufficient quality or quantity for mutation testing. Noninvasive techniques for tumor genotyping may be needed to fully realize, such as plasma sample. Cell-free DNA (cf-DNA) in plasma is a kind of fresh and realtime sample, and has been shown to be promising for the detection of sensitizing EGFR mutations even the resistance mutation（T790M). However, a challenge was also raised about how to detect the low abundance of mutant alleles in plasma. In our study Droplet Digital polymerase chain reaction and Realtime polymerase chain reaction will be used to assess the EGFR mutation in plasma DNA samples from patients with advanced NSCLC before and after EGFR tyrosine kinase inhibitors therapy.

Eligibility: Inclusion Criteria:
  1. Aged 18-85 years old;
  2. The diagnosis of lung cancer by pathological examination;
  3. At least one specific measurable lung cancer lesions (according to RECIST criteria, application of spiral CT, the lesion diameter 10 mm or higher);
  4. People understand and are willing to accept the study, and sign the informed consent
  Exclusion Criteria:
  1. With severe hemorrhagic disease;
  2. Compliance is poor, can't cooperate with the visitor.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Study of Prevalence of EGFR Mutations in Participants With NSCLC

Summary: This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Informed consent form signature
  -  Jordanian male and female participants greater than or equal to (>=) 18 years of age
  -  Histologically confirmed NSCLC
  -  Not participating in a study that involves an investigational agent within 30 days prior to enrollment
  Exclusion Criteria:
  -  Other primary malignancy
  -  Fine needle aspiration samples

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Summary: Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
  Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
  Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
  Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility: Principal Inclusion Criteria:
  -  Stage III or IV NSCLC, non irradiable non operable
  -  Non squamous NSCLC histologically or cytologically confirmed
  -  No previous treatment of NSCLC
  -  EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  -  Presence of at least one lesion that can be measured
  -  PS 0 or 1
  Principal Exclusion Criteria:
  -  Symptomatic brain metastasis or requiring immediate radiotherapy
  -  T790M mutation or exon 20 insertion
  -  Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  -  Interstitial pneumopathy

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: In Vivo EGFR Molecular Classification

Summary: The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.

Detailed description: The goal of investigators were to evaluate the use of 18F-MPG as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-MPG in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers.

Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  18 years or older
  -  A life expectancy of at least 12 weeks
  -  Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
  -  Written informed consent
  Exclusion Criteria:
  -  Claustrophobia
  -  Pregnancy
  -  Metal implants in the thorax

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation

Summary: This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.


Eligibility: Inclusion Criteria:
  1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
  2. Positive EGFR mutation(19 exon or 21 exon)。
  Exclusion Criteria:
  1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
  2. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  3. Allergic to icotinib
  4. metastases of spinal cord, meninges or meningeal.

Relevance to patient case: possibly relevant