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

Clinical trial: NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.

Summary: The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Detailed description: Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable EGFR mutant stage III NSCLC.

Eligibility: Inclusion Criteria:
  -  Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21
  -  Written informed consent provided
  -  Aged 18-75 years
  -  Able to comply with the required protocol and follow-up procedures
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  -  Had a life expectancy of 12 weeks or more
  -  Adequate hematological function, liver function and renal function
  -  Female participants should not be pregnant or breast-feeding
  Exclusion Criteria:
  -  Known severe hypersensitivity to gefitinib or any of the excipients of this product
  -  Inability to comply with protocol or study procedures
  -  Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)
  -  Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder
  -  Interstitial pneumonia
  -  Eye inflammation not fully controlled or conditions predisposing the subject to this
  -  Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
  -  Known human immunodeficiency virus (HIV) infection
  -  Pregnancy or breast-feeding women
  -  History of neurologic or psychiatric disorders
  -  Ingredients mixed with small cell lung cancer patients

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

Clinical trial: Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Summary: The purpose of this study is to determine if Itacitinib in combination with erlotinib is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.

Detailed description: The study consists of an open-label, safety run-in to confirm the safety of Itacitinibin combination with erlotinib in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent whose tumors have EGFR activating mutations. Subjects in the safety run-in will receive open-label Itacitinib and erlotinib.
  In the second part of the study, subjects will be enrolled and randomized to receive erlotinib (open-label) and either Itacitinib or placebo in a blinded manner. The dose of Itacitinib administered will be determined from the data produced in the safety run-in phase.
  Treatment will consist of repeating 21-day cycles. Subjects will take erlotinib tablets daily and Itacitinib/placebo will be self-administered daily during the entire cycle.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB, Stage IV, or recurrent (including Stage II).
  -  Documented evidence of an activating mutation in EGFR in tumor samples (exon 19 deletions or point mutation L858R in exon 21 or point mutations at codon 719).
  -  A mGPS of 1 or 2 as defined below:
  -  Criteria: C-reactive protein >10 mg/L AND albumin ≥35 g/L Score-1
  -  Criteria: C-reactive protein >10 mg L AND albumin <35 g/L Score-2
  -  Radiographically measurable or evaluable disease.
  -  Life expectancy of at least 12 weeks.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  -  Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
  Exclusion Criteria:
  -  Known presence of the T790M mutation in EGFR in tumor samples
  -  Candidates for curative radiation therapy or surgery.
  -  Previous systemic chemotherapy for advanced disease, including EGFR inhibitor therapy, except subjects who received 1 cycle of chemotherapy while waiting to receive EGFR results, who may enroll provided that 21 days have elapsed from end of chemotherapy to the day to the baseline radiographic measurement prior to Cycle 1 Day 1.
  -  Distinct or suspected, or history of, pulmonary fibrosis or ILD.
  -  Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive indolent or Stage I malignancy without sponsor approval.

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

Clinical trial: Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer

Summary: In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in patients who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

Detailed description: In this phase II trial, the investigators evaluate the efficacy and safety of S-588410 containing oncoantigens-derived HLA-A*2402-restricted epitope peptides in patients with HLA-A*2402 who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

Eligibility: Inclusion Criteria:
  1. Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
  2. Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
  3. Patients with HLA-A*24:02.
  4. Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
  5. Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
  6. ECOG performance status 0 or 1 within 2 weeks prior to the registration.
  7. Age over 20 years at time of consent acquisition.
  8. The written informed consent provided by the patient.
  Exclusion Criteria:
  1. Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
  2. Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
  3. Active and uncontrolled infectious disease.
  4. Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
  5. Coronary artery stenting within 6 months prior to registration.
  6. Autoimmune disease.
  7. HIV infection.
  8. Registration within 4 weeks after the last adjuvant chemotherapy.
  9. Laboratory values defined in the protocol within 2 weeks prior to registration.
  10. Residual uncontrolled adverse events by adjuvant chemotherapy.
  11. Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
  12. Past history of severe allergic reaction against drug, vaccine and biological agents.
  13. Female patient in nursing or pregnancy.
  14. Refusal of pregnancy conception.
  15. Treated with the same peptide vaccines as S-588410.
  16. Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
  17. Decision of non-enrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

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

Clinical trial: Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)

Summary: In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Detailed description: Non small lung cancer will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as immunotherapy.

Eligibility: Inclusion Criteria:
  1. Age:18-75
  2. Karnofsky performance status >50
  3. Diagnosis with non small lung tumors based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK.
  5. Life expectancy: Greater than 3 months
  6. Ability to understand the study protocol and a willingness to sign a written informed consent document
  Exclusion Criteria:
  1. Patients with other kinds of cancer
  2. History of coagulation disorders or anemia
  3. Patients with heart disease and diabetes

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

Clinical trial: Chemotherapy of NSCLC With or Without Icotinib

Summary: Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.


Eligibility: Inclusion Criteria:
  -  Patients undergoing completely resection of EGRF mutation-positive NSCLC
  -  Staging ⅠB (with high risk factor) to ⅢA
  -  PS = 0 or 1
  -  Adequate hematological, biochemical and organ functions
  Exclusion Criteria:
  -  Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating

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 as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

Summary: Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed non-small cell lung cancer after surgical resection
  -  Stage II-IIIA disease according to 7th edition of TNM staging
  -  Positive EGFR gene mutation (19/21)
  -  ECOG 0-1
  -  At least 1-year life expectancy
  -  Adequate organ function
  Exclusion Criteria:
  -  Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  -  Pneumonectomy of right lung
  -  Any unresolved chronic toxicity from previous anticancer therapy
  -  Allergic to study drug

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

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

Detailed description: The decision was taken to halt study enrollment with Cohort #3 in Phase 1b. Therefore, activities for the planned Phase 2 were not initiated.
  This decision to stop further development of this combination was taken due to the challenge for enrollment in this very rare patient population along with the rapidly evolving disease landscape setting.

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

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

Clinical trial: Afatinib Genomic Landscape

Summary: The investigators propose to conduct a pilot feasibility study of single agent afatinib in patients with previously untreated metastatic EGFR (epidermal growth factor receptor) mutant adenocarcinoma of the lung (NSCLC = non-small cell lung cancer) with the sole purpose of characterizing the genomic landscape before afatinib and at the time of disease progression.

Detailed description: The current proposal will include exome and transcriptome sequencing from blood collected at baseline along with tumor samples obtained prior to starting afatinib and at the time of disease progression (a total of two tissue samples and one blood sample per patient). The samples will be collected via consent to the IRB (Institutional Review Board) approved banking study "Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma".
  If carried out successfully, the proposed strategy very likely will lead to a larger and adequately powered study (perhaps using whole genome sequencing) to understand fully evolving molecular changes due to clonal selection under treatment pressure. The pace of progress in the field of sequencing technology currently underway is only likely to accelerate in the near future yielding richer and highly content-rich information. Moreover, it is likely that genomic information from DNA sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes.
  Successful completion of the proposed study would enable future studies to fully harness the potential of emerging technologies to develop novel approaches to treat and even ideally prevent resistance to EGFR TKIs (tyrosine-kinase inhibitor) and other molecularly targeted therapies. This could serve as a template for other cancer types as well. Over time, this approach, broadly used, would create simultaneously, highly valuable annotated tumor specimens along with germ line DNA for high-throughput genomic studies to identify novel targets and their impact on the course of disease. Re-analyzing molecular changes in the tumor at the time of disease progression would likely be a new standard of care to guide salvage therapy.

Eligibility: Inclusion Criteria/Exclusion Criteria:
  -  Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma
  -  Presence of known sensitizing mutations in EGFR TK domain (exon 19 deletion and L858R)
  -  Absence of known resistant mutations in the EGFR TK domain (T790M)
  -  Consented to HRPO # 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma")
  -  No prior treatment for this malignancy
  -  No prior localized therapy to the biopsy site
  -  Planned treatment with standard of care afatinib at 40 mg QD (daily)
  -  Not pregnant or breastfeeding
  -  At least 18 years of age

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

Clinical trial: Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer

Summary: Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.
  Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.
  Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.
  Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.
  The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.
  However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.
  It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.
  The final aim is to optimize survival by an adapted metabolic imaging guided therapy.

Detailed description: The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer.
  The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response.
  80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.

Eligibility: Inclusion Criteria:
  -  Age superior to 18 years old
  -  Effective contraception method or negative pregnancy test at the inclusion
  -  OMS inferior or equal to 1
  -  Non-small cell lung cancer stage IIIb or IV
  -  Non progressive disease after at lest 4 cycles of platinum-based chemotherapy
  -  Eligible fo maintenance therapy with bevacizumab and/or pemetrexed
  -  Inform consent signed
  Exclusion Criteria:
  -  Evolution of a second cancer in the 3 years before inclusion
  -  Pregnancy or breast-feeding
  -  poorly controlled diabetes
  -  curatorship or guardianship
  -  contraindication to iodinated contrast agents
  -  participation to another clinical research with an experimental drug
  -  impossible decubitus
  -  not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons

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

Clinical trial: Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

Summary: Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

Detailed description: This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.
  To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 and ≤80 years.
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  At least one measurable lesion exists.(RECIST 1.1)
  -  Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
  -  Required laboratory values including following parameters:
  ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
  -  Signed informed consent.
  Exclusion Criteria:
  -  Subjects with third space fluid that can not be controled by drainage or other methods.
  -  Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  -  Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
  -  Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  -  Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  -  Receiving any other antitumor therapy.
  -  Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
  -  History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  -  Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  -  Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  -  Known history of neurological or psychiatric disease, including epilepsy or dementia.

Relevance to patient case: not relevant