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

Clinical trial: RT Plus EGFR-TKI for Wild-type NSCLC

Summary: Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.


Eligibility: Inclusion Criteria:
  1. NSCLC confirmed by histopathology or cytology;
  2. Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
  3. Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  5. Expectancy life >= 3 months;
  Exclusion Criteria:
  1. Had systemic anit-NSCLC treatments;
  2. Had be treated by HER-targeting agents;
  3. Had local radiotherapy for NSCLC;
  4. Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  5. Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  6. Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  7. Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
  8. Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
  9. Pregnancy or breast-feeding women;
  10. Ingredients mixed with small cell lung cancer patients;
  11. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.

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

Clinical trial: PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)

Summary: Objectives:
  To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.
  Eligibility:
  Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.

Detailed description: A total of 20 patients may be enrolled over a period of 1-2 years.

Eligibility: Inclusion Criteria:
  1. Age 18~65 years old, male or female;
  2. Life expectancy≥6 months;
  3. ECOG score: 0-3;
  4. Advanced solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians;
  5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
  6. Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and IGFR1 protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
  7. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
  8. Signed informed consent；
  9. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
  Exclusion Criteria:
  1. Expected Overall survival ＜ 6 months;
  2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
  3. Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%;
  4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
  5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

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

Clinical trial: EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

Summary: The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).

Detailed description: This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).
  Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.
  The endpoint of this study included clinical efficacy and safety.

Eligibility: Inclusion Criteria:
  -  Stage Ⅳ EGFR mutation-positive NSCLC
  -  Initial therapy
  -  ECOG performance status 0-1
  Exclusion Criteria:
  -  EGFR mutation-negative
  -  Previous systemic antitumour treatment

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

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: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

Summary: The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Histologically confirmed adenocarcinoma;
  -  EGFR-wildtype NSCLC;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  -  Provision of blood (plasma) sample for ctDNA testing;
  Exclusion Criteria:
  -  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: Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

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

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

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

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

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

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

Clinical trial: Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

Summary: This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation


Eligibility: Inclusion Criteria:
  -  Patients with stage IIIB/IV non-small cell lung cancer
  -  Patients with uncommon epidermal growth factor receptor (EGFR) mutation
  -  Targeted-therapy-naive patients
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  -  Evaluable target lesions according to RECIST 1.1 for tumour response assessment
  Exclusion Criteria:
  -  Wild-type EGFR
  -  Positive 19 del and/or 21 L858R mutation
  -  Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
  -  Patients who have documented history of interstitial lung disease

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 TAS-116 in Patients With Solid Tumors

Summary: A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.


Eligibility: Inclusion Criteria:
  1. Male or females with an age ≥ 18 years (≥ 20 years in Japan)
  2. Patients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
  a. Part C: Only the following subtype of tumors with the molecular/genetic alterations will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after progression on osimertinib Advanced NSCLC, harboring ALK translocations after treatment with alectinib or at least 2 ALK inhibitors
  3. Has At least one measurable lesion as defined by RECIST criteria
  4. Is able to take medications orally (e.g., no feeding tube).
  5. Is able to agree to and sign informed consent and to comply with the protocol
  6. Has adequate organ function
  Exclusion Criteria:
  1. Has a serious illness or medical condition(s)
  2. Has received treatment with any prescribed treatments within specified time frames prior to study drug administration
  3. Significant ophthalmologic abnormality,
  4. Impaired cardiac function or clinically significant cardiac disease

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

Clinical trial: Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type

Summary: This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV.

Detailed description: This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV. Chinese herbal medicine was known to be beneficial adjuvant or alternative medicine for cancer treatment. However, the mechanism was unknown. This study wants to investigate the effect and mechanism of YQ1, which was proved to improve the antitumor immunity, to inhibit cancer progression, and to prolong overall survival of lung adenocarcinoma in a series of preclinical studies.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV), EGFR/ALK wild type.
  -  Subjects who plan to receive cisplatin-based chemotherapy.
  -  Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
  Exclusion Criteria:
  -  ECOG performance status >= 3
  -  WBC =< 4,000 cells/μl, ANC =< 1,500/mcL, Platelets =< 100,000/mcL , Hemoglobin =< 9 g/dL,
  -  Total bilirubin >= 1.5 x upper limit of normal (ULN), AST >= 1.5x ULN, ALT >= 2.5 x ULN, Creatinine >= 1.5x ULN
  -  Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure.
  -  Chronic or current Inflammatory Bowel Disease, post-surgery of intestine, Lynch syndrome, FAP, Peutz-Jegher.
  -  History of allergic reactions cisplatin
  -  Pregnant women are excluded; breastfeeding should be discontinued prior to study entry.
  -  Received any other clinical trail at the same time.
  -  Current dementia or other cognitive disorders.

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

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

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

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

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

Relevance to patient case: not relevant