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

Clinical trial: KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

Summary: The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.


Eligibility: Inclusion Criteria:
  -  1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
  -  2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
  Exclusion Criteria:
  -  1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
  -  2. Pregnancy and/or breast feeding
  -  3. Current participation in any interventional trial

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

Clinical trial: PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

Summary: The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.


Eligibility: Inclusion Criteria - Primary Study Cohort
  -  Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)
  -  Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  -  Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC
  -  Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period
  Inclusion Criteria - Secondary Study Cohort
  -  Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)
  -  Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  -  Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M).
  Exclusion Criteria - Primary and Secondary Study Cohorts
  • Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.

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 of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer

Summary: To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.


Eligibility: Inclusion Criteria:
  -  Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer;
  -  All sites of disease must be amenable to definitive radiotherapy;
  -  Age 18 years to 75 years;
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
  -  Forced expiratory volume in 1 second(FEV1)> 0.75L;
  -  No previous chest radiotherapy, immunotherapy or biotherapy;
  -  Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
  -  For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
  -  Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;
  -  Patients and their family signed the informed consents;
  Exclusion Criteria:
  -  Active infection;
  -  History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias);
  -  Malnutrition (loss of ≥ 20% of the original body weight);
  -  Performance status: 3-4;
  -  Sensor or motor neuropathy > grade I;
  -  Second primary malignancy, except for non-melanoma skin cancer;
  -  Psychiatric illness or social situation that would preclude study compliance;
  -  Pregnant or lactating women.

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

Clinical trial: Acquired Resistant Mechanism of the First-generation EGFR TKIs

Summary: Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).


Eligibility: Inclusion Criteria:
  -  Histologically proven stage IIIB or IV non-small cell lung cancer
  -  patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
  -  patients who can provide pre-treatment (EGFR TKIs) tumor tissues
  -  patients with tumor lesions to be re-biopsy after drug resistance
  -  patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.
  Exclusion Criteria:
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  patients with other systemic diseases

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

Clinical trial: A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in NSCLC Patients With EGFR Mutation Who Failed 1L or 2L EGFR TKI Therapy

Summary: The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib).
  -  No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy.
  -  Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  -  Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC). For subjects who were treated with osimertinib, T790M testing is not required.
  -  Subjects are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Subjects with asymptomatic CNS metastasis are eligible.
  -  Eastern Cooperative Group (ECOG) Performance Status 0-1
  -  Life expectancy is at least 3 months
  Exclusion Criteria:
  -  Subjects with known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These subjects are only eligible if they fail osimertinib as 2L.
  -  Subjects who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
  -  Subjects with carcinomatous meningitis
  -  Subjects with an active, known or suspected autoimmune disease are excluded
  -  Subjects with ALK translocation
  -  Subjects with known SCLC transformation
  -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  Other protocol defined inclusion/exclusion criteria could apply

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

Clinical trial: Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment

Summary: The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.

Detailed description: This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.
  Exclusion Criteria:
  -  Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.

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

Clinical trial: In Vivo EGFR-ECD Molecular Imaging Using [68Ga]- Labelling Anti-EGFR Affibody Molecule

Summary: The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.

Detailed description: The goals of investigators are to evaluate the use of [68Ga]-labelling Anti-EGFR Affibody Molecule as a novel PET/CT radiotracer to monitor EGFR-ECD expression status and classify EGFR-ECD benefit NSCLC patients. The investigators want to evaluated the use of [68Ga]-labelling Anti-EGFR Affibody Molecule in lung cancer imaging in adult NSCLC patients with different EGFR-ECD expression 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: not relevant
Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

Clinical trial: Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Summary: Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.


Eligibility: Inclusion Criteria:
  -  local advanced or metastatic non-small cell lung cancer
  -  large cell lung carcinoma or adenocinoma
  -  Previously treated by TKI-Chemotherapy or Chemotherapy-TKI
  -  EGFR T790M positive
  -  No uncontrolled hypertension
  -  No active bleeding or thrombosis in recent 6 months
  -  No previously treated with VEGF antibody
  Exclusion Criteria:
  -  newly diagnosed thrombosis
  -  anti-coagulation therapy
  -  uncontrolled hypertension
  -  uncontrolled nephropathy

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

Clinical trial: High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Summary: The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC
  -  Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment
  -  Patients whose tumors:
  -  are EGFR mutation-positive or
  -  T790M mutation-negative
  -  Performance status: WHO 0-2
  -  Measurable disease according to RECIST 1.1
  -  at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology
  -  a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm
  -  ANC ≥ 1.5*109/L, Platelets ≥ 75*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN
  -  Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
  -  Patient must be able to comply with the protocol
  Exclusion Criteria:
  -  Patient with symptomatic central nervous system metastases
  -  Patient has known active hepatitis B or C, or HIV infection
  -  Pregnant or breastfeeding.
  -  Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the 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: ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory

Summary: The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.

Detailed description: This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
  2. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
  3. Patients who have progressed following prior therapy with an EGFR-TKI agent.
  4. Patients who consent to provide tumour tissue and/or blood.
  Exclusion Criteria:
  1. Patients who disagree to participate this study.
  2. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.

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

Clinical trial: PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients

Summary: The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.

Detailed description: Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients.
  explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.

Eligibility: Inclusion Criteria:
  1. The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
  2. The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
  3. Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening.
  4. Fine needle aspirate specimens are not acceptable.
  5. Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
  6. The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred in formalin-fixed paraffin embedded blocks.
  Exclusion Criteria:
  1. The patient does not have sufficient tumor tissue specimen available for detection.
  2. The Patient who is unwilling to use the existing data from medical practice for scientific research.
  3. The patient who received immunotherapy therapy before.

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

Clinical trial: Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC

Summary: To assess the effectiveness and safety of osimertinib treatment in a real world setting.

Detailed description: The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.

Eligibility: Inclusion Criteria:
  -  Above 18 years of age;
  -  Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
  -  Confirmed T790M mutation
  -  Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
  -  Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016
  Exclusion Criteria:
  • Enrolment in studies that prohibit any participation in this observational study

Relevance to patient case: definitely relevant