araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

Summary: The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed description: Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Eligibility: Inclusion Criteria:
  -  Brazilian patients with metastatic non-small cell lung cancer.
  Exclusion Criteria:
  -  Small cell lung cancer and non-metastatic patients.

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

Summary: To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.

Detailed description: This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.

Eligibility: Inclusion Criteria:
  -  Patients enrolled in AZD9291 Named Patient Program in Hong Kong
  -  Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation
  -  Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study
  -  Provision of written informed consent (for patients alive at the time of study enrolment)
  -  Documented patients with trackable medical records
  Exclusion Criteria:
  -  Enrolment in studies that prohibit any participation in this non-interventional study

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Summary: Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

Detailed description: The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Eligibility: Inclusion Criteria:
  1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
  2. Age of 18 years or older.
  3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
  4. Participants must have hemoglobin > 10 mg/dL.
  5. Ability to understand and willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hepatitis (all types) in patient's medical record
  2. HIV documented in patient's medical record
  3. Hemoglobin < 10 mg/dL
  4. Less than 18 years of age
  5. Histologically confirmed NSCLC Stage I-IIIA
  6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)

Summary: A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.


Eligibility: Inclusion Criteria:
  -  Stage IIIB or IV NSCLC (any histology) at the time of study entry
  -  Histologically or cytologically confirmed diagnosis of NSCLC that is:
  1. EGFR wt as per patient standard of care by a validated test
  2. AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  3. AND (by central assessment) either:
  -  Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
  -  Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
  -  Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
  -  Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  -  At least one measurable lesion as defined by RECIST 1.1
  -  Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
  -  Patients must have adequate organ function
  -  ECOG performance status (PS) of 0 or 1
  Details and other protocol-defined inclusion criteria may apply
  Exclusion Criteria:
  -  Prior treatment with crizotinib, or any other cMET or HGF inhibitor
  -  Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
  -  Patients with characterized ALK-positive rearrangement
  -  Clinically significant, uncontrolled heart diseases.
  -  Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
  -  Strong and moderate inhibitors of CYP3A4
  -  Strong inducers of CYP3A4
  -  Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  -  Patients receiving treatment with any enzyme-inducing anticonvulsant
  -  Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  -  Pregnant or nursing women
  -  Women of child-bearing potential, unless they are using highly effective methods of contraception
  -  Sexually active males unless they use a condom during intercourse
  Other protocol-defined exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer

Summary: this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.
  -  Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS，any positive).
  -  unavailable of radical surgery or radical radiotherapy.
  -  not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.
  -  Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.
  -  Age 18-75 years old with performance status of 0 to 3.
  -  With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.
  -  Adequate hematological, biochemical and organ functions.
  Exclusion Criteria:
  -  Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  -  Evidence of interstitial lung diseases
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  -  Other situations researchers think not appropriate to enter the group

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Afatinib Osimertinib Sequencing NIS

Summary: This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.


Eligibility: Inclusion Criteria:
  -  Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
  -  The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
  -  Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
  -  Patients treated with osimertinib within an EAP/CUP or regular clinical practice
  -  Age ≥ 18 years
  -  Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)
  Exclusion Criteria:
  -  Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
  -  Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

Summary: In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenecity.

Detailed description: This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
  Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.

Eligibility: Inclusion Criteria:
  -  Aged ≥ 18 years
  -  ECOG performance status of 0-1
  -  Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
  -  At least one measurable lesion according to RECIST v1.1.
  -  Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters
  Exclusion Criteria:
  -  Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
  -  Sensitizing EGFR mutations or ALK rearrangements
  -  Increased risk of bleeding determined by investigator based on radiographic / clinical findings
  -  History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC

Summary: Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.

Detailed description: Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
  -  Electronics Coordinating Grop（ECOG）score：0-2
  -  Expected survival over 3months
  -  Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）<2.5 ULN；Cr≤1.25ULN
  Exclusion Criteria:
  -  Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
  -  Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
  -  Hemorrhoid dysfunction (inernational standard ratio(INR)> 1.5 or prothrombin time (PT)> ULN + 4 seconds or activated partial thromboplastin(APTT)> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  -  Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
  -  Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
  -  Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer

Summary: This is a Phase I, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations who have progressed following treatment with an EGFR inhibitor.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Histologically or cytologically confirmed metastatic or advanced inoperable diagnosis of non-small cell lung cancer (NSCLC)
  -  Radiographic documentation of disease progression while on previous continuous treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
  -  All subjects must fulfill one of the following:
  1. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity OR
  2. Must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria followed by systemic objective progression while on continuous treatment with EGFR TKI
  -  Dose Expansion cohort(s): subjects in the dose expansion cohorts must also have confirmation of tumor T790M mutation status (confirmed positive) by cobas® EGFR Mutation Test v2 from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) plasma sample taken after disease progression on the most recent treatment regimen (EGFR TKI or chemotherapy or other therapy).
  Exclusion Criteria:
  -  Treatment with an EGFR TKI within 10 days or 5 half-lives of the first dose of study treatment, whichever is longer
  -  Dose Expansion cohorts: Prior treatment with osimertinib (Tagrisso®). Prior treatment with osimertinib (Tagrisso®) is allowed for subjects participating in the dose escalation portion of the study
  -  Cytotoxic chemotherapy, investigational agents, or any anticancer therapy for the treatment of advanced NSCLC (other than EGFR TKI) within 21 days of the first dose of study treatment
  -  Prior treatment with immunotherapy (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab) within 6 months of cycle 1 day 1
  -  Known intermediate or strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days prior to first dose of study treatment

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer

Summary: The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer

Detailed description: The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

Eligibility: Inclusion Criteria:
  -  Patients with radical resection of lung cancer enrolled from 2014 to 2019;
  -  Pathologically diagnosed patients with non-small cell lung cancer;
  -  Patients with age > 18 years old;
  -  Patients who did not receive chest surgeries before hospitalization;
  -  Patients with N2 lymph nodes (+) after surgeries;
  -  Patients who received lymphadenectomy for one group or more groups of lymph nodes;
  Exclusion Criteria:
  -  Patients with second primary tumors or multiple primary tumors;

Relevance to patient case: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

Summary: This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.
  The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and dose-finding portion (Part 1), and randomized portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients will be enrolled in the study.


Eligibility: Inclusion Criteria:
  -  Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity
  -  For Part 2, EGFR T790M mutation-positive tumor status
  -  Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range
  -  For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1
  -  For Part 2, measurable disease as defined by RECIST, Version 1.1
  -  ECOG performance status 0 to 1
  -  Adequate organ function
  Exclusion Criteria:
  -  Prior treatment with EGFR TKI within 9 days of first study dose
  -  For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC
  -  For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI
  -  For Part 2, prior chemotherapy for advanced NSCLC
  -  Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  -  Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose
  -  Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
  -  Prior hematopoietic stem cell or bone marrow transplantation

Relevance to patient case: definitely relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer

Summary: AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Detailed description: AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Eligibility: Inclusion Criteria:
  -  At least 20 years of age
  -  Patients who were in the AZD9291 Early Access Program
  -  Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents
  -  Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018
  -  Patients agree to provide the written informed consent or the informed consent is waived by IRB.
  Exclusion Criteria:
  • Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC

Relevance to patient case: definitely relevant