araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

Summary: This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.

Detailed description: Lobectomy has long been considered the standard procedure for early-stage lung cancer, and minimally invasive techniques have been demonstrated to be associated with superior outcomes compared with lobectomy by thoracotomy. the us of segmentectomy is under investigation for selected patients with small tumors, and the use of minimally invasive strategies is applicable as well.
  This nationwide, multicenter, prospective, randomized open phase III study of cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy versus Lobectomy for stage IA non-small cell lung cancer (NSCLC) patients with Lung adenocarcinoma in situ or with microinvasion, is aiming to evaluate the relapse free survival and 5 year overall survival (OS) rate of two types of surgery. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo cVATS lobectomy.
  -  Arm II: Patients undergo cVATS segmentectomy.
  Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.

Eligibility: Inclusion Criteria:
  Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1 second);
  Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas < 0.5cm);
  Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications;
  Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion;
  No prior ipsilateral thoracotomy;
  No prior anti-neoplastic therapy;
  EOCG Performance status 0-2;
  Sufficient organ functions;
  Written informed consent.
  Exclusion Criteria:
  Active bacterial or fungous infection;
  Simultaneous or prior (within the past 5 years) other malignant disease;
  Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease);
  Abnormal Psychosis;
  Uncontrollable diabetes mellitus;
  History of severe cardiovascular disease;
  Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Summary: This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of advanced non-small cell lung cancer
  -  Written documentation of KRAS (exon 2, 3 or 4) mutation
  -  At least 18 years of age or older
  -  Able and willing to give written informed consent
  -  WHO performance status of 0 or 1
  Exclusion Criteria:
  -  Symptomatic or untreated leptomeningeal disease
  -  Symptomatic brain metastasis
  -  Impairment of gastrointestinal function
  -  Uncontrolled infectious disease
  -  Left ventricular ejection fraction < 50%
  -  Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

Summary: Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
  Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
  The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.


Eligibility: Inclusion Criteria:
  -  Patient is male or female, and > 18 years of age
  -  Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
  -  Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
  -  Patient has agree to participate by giving written informed consent
  Exclusion Criteria:
  -  metastatic pancreatic tumor
  -  cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
  -  minor patient under 18 years
  -  contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
  -  patient under guardianship
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Erlotinib Combined With Chemotherapy in TKI Resistant Non-Small Cell Lung Cancers

Summary: Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

Detailed description: The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. After enrollment, the investigators will do biopsy again before second line treatment to find out the potential mechanism of TKI resistance, do EGFR mutation test for both sensitive and resistant mutation in exon 18, 19, 20 and 21; do KRAS, BRAF and PI3K mutation test, do FISH for MET and HER-2, the investigators do all these test to evaluated both primary and secondary resistance, the investigators do all these tests to get an overview for EGFR mutation status of each patient who develop TKI resistance. For second line treatment, patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease. For the patients who have stable brain metastases, combined chemotherapy should begin after local treatment, such as whole brain radiotherapy or sterotactic radiosurgery.
  the main endpoint of this study is mean PFS, second endpoints of this study consist of mean OS, 8 week ORR.

Eligibility: Inclusion Criteria:
  -  advanced non-small cell lung cancer, stage IIIB/IV
  -  non-squamous
  -  EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R
  -  received first line TKIs treatment and developed TKI resistance
  -  ECOG 0-2
  Exclusion Criteria:
  -  squamous non-small cell lung cancer
  -  patients have unstable brain metastasis, predict survival less than 8 weeks
  -  spinal-cord compression without evidence of stabilisation or treatment
  -  women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline
  -  patients have any unstable illness that could not receive further treatment

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Registry Measuring the Impact of Adding RNA Expression Testing on Referral Decisions in Early Stage Lung Cancer Patients and Assessing the Disease-free Survival With Long-term Follow-up

Summary: This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment decisions of Surgeons when added to standard clinical-pathological parameters in patients with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be collected.


Eligibility: Inclusion Criteria:
  -  Diagnosis of early stage non-small cell lung adenocarcinoma
  -  Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site
  -  Resection of tumor within previous 2 months of enrollment
  -  ECOG performance of 0-2
  -  A minimum life expectancy of six months
  Exclusion Criteria:
  -  Pre-operative radiation or chemotherapy for NSCLC
  -  Post-operative radiation or chemotherapy for NSCLC
  -  Enrollment in a separate clinical trial restricting treatment options
  -  Unable to provide informed consent

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

Summary: The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed description: This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
  Primary Outcome Measure:
  Disease-free survival between Icotinib group and placebo group.
  Secondary Outcome Measures:
  Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed lung adenocarcinoma after surgical resection
  -  Stage II-IIIA disease according to 7th edition of TNM staging
  -  Patients must harbor sensitive EGFR gene mutation (19/21)
  -  Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy
  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
  -  Presence of metastatic disease
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  -  Any unresolved chronic toxicity from previous anticancer therapy
  -  Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2

Summary: The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of Lung adenocarcinoma
  -  Postoperative staging pN2 period
  -  Voluntary participation and informed consent
  -  Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
  -  performance status( PS) score 0-2.
  -  Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
  -  Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) <upper limit of normal (ULN) of 1.5 times, bilirubin <1.5 × ULN.
  -  Renal function: serum creatinine <1.5 × ULN.
  -  Compliance, and can be regular follow-up, voluntary compliance with study requirements
  Exclusion Criteria:
  -  Do not meet the inclusion criteria
  -  There is evidence of distant metastases
  -  Suffered from other malignancies in five years
  -  Within the past January subjects received other drug trials
  -  Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
  -  Severe lung or heart disease, a history
  -  Refuses or is unable to sign informed consent to participate in trials
  -  The abuse of drugs or alcohol addicts.
  -  Patients with difficult to control bacterial, viral, fungal infections
  -  Having a personality or mental disorders, without civil capacity or restricted civil capacity.
  -  Being pregnant or lactating women.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

Summary: To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma


Eligibility: Inclusion Criteria:
  1. Able to read and understand the informed consent document; must sign the informed consent;
  2. Aged 18 to 75 years old , sex is not limited;
  3. Pancreatic cancer or primary liver cancer,must have undergone radical resection;
  4. Availability of at least 0.5 g tumor sample;
  5. Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation;
  6. Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment；
  7. ECOG ≤1；life expectancy of at least 12 weeks
  8. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] and bilirubin (total) <1.5 times IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs); 9. Agree to Surgical indications of Heart & lung and without the coagulation system disease;
  10.Negative pregnancy test for female patients of childbearing potential; 11.Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration.
  Exclusion Criteria:
  1. Unable to get the informed consent ;
  2. Patient not suitable for radical resection;
  3. Patients with active liver disease；
  4. Did not get enough tumor tissue ;
  5. Progression prior to vaccination as determined by the Principal Investigator;
  6. Rreceiving other anti-cancer therapy at the same time;
  7. Patient with allergic constitution;
  8. Unstable or severe intercurrent medical conditions;
  9. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection;
  10. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids;
  11. Any other cilical trials within 30 days pre-vaccination;
  12. Female patients who are pregnant or breastfeeding.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Summary: The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.


Eligibility: Inclusion Criteria:
  -  Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook.
  -  Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study central laboratory. A KRAS positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per local laboratory will be permitted in no more than 10% of randomized participants.
  -  Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible.
  -  Have measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  -  Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.
  Exclusion Criteria:
  -  Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
  -  Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  -  Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging [MRI]) within 28 days of randomization to document stability, even if there have been no changes in symptoms.
  -  Have previously completed or withdrawn from this study or any other study investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6) inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.

Relevance to patient case: possibly relevant