araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients

Summary: This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact and resistance mechanisms of panitumumab in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC).
  This study will address two anticipated issues surrounding personalized medicine and treatment with panitumumab. First, it will enable to assess the economic impact of panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic colorectal cancer (Blood study).
  The primary objective is to collect information on quality of life and health care resource utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. The blood biomarker study objective is to determine blood-based biomarkers of response or resistance to panitumumab.
  Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab and will participate to the HEOR study and to the blood biomarker study.
  During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation. For patients participating to the blood study (patients with a wild type KRAS), blood samples will be collected before patients start their treatment, at every treatment and when they discontinue their treatment.


Eligibility: Inclusion Criteria:
  -  Patients with a histologically confirmed diagnosis of mCRC.
  -  Immunohistochemical evidence of EGFR expression.
  -  ECOG performance status of 0, 1 or 2.
  -  Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
  -  Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC.
  -  Signed and dated IRB-approved informed consent document.
  -  Ability to read and understand English or French.
  -  18 years of age or older.
  Exclusion Criteria:
  -  Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Study to Evaluate Real-world Pharmacoeconomics of Panitumumab in Metastatic Colorectal Cancer Patients

Summary: This is a phase IV multicenter trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC).
  The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population.
  The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients.
  Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab.
  During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation.


Eligibility: Inclusion Criteria:
  -  Patients with a histologically confirmed diagnosis of mCRC.
  -  Immunohistochemical evidence of EGFR expression.
  -  ECOG performance status of 0, 1 or 2.
  -  Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
  -  Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC.
  -  Signed and dated IRB-approved informed consent document.
  -  Ability to read and understand English or French.
  -  18 years of age or older.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

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
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: The Oncopanel Pilot (TOP) Study

Summary: The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes.
  The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.

Detailed description: Somatic mutations in solid tumors represent an established means of characterizing malignancies for prognostic, diagnostic and therapeutic purposes. Mutations in EGFR, KRAS, BRAF, and KIT and PDGFRA genes direct therapy in patients with advanced lung, colorectal, melanoma, and GIST tumors, respectively. Known or novel mutations in other genes may also be of clinical significance but are not identified by current genotyping offered to BC Cancer Agency (BCCA) patients. Furthermore, numerous candidate genes have been implicated as potential prognostic and predictive biomarkers in patients with solid tumours. As such, the Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The following clinically relevant set of genes and exons are included in the Oncpanel: KRAS, EGFR, BRAF, NRAS and HRAS, PIK3CA Signal Transduction Pathway Genes, RAS-RAF-MEK-MAPK Pathway, HER2, IDH1 and IDH2, ALK, TP53, c-KIT, STAT1&3 and PDGFRA. Additional testing on the tumour material will also include analysis of specific gene variants associated with adverse events or response to therapy.
  Numerous studies have documented the presence of circulating tumour DNA (ctDNA) among patients with advanced and early stage malignancies (20-22). The ability to diagnose standard cancer mutations with a blood-based assay (a "liquid biopsy") has not yet been established but presents obvious advantages. The emergence of "resistance" mutations arising in the metastatic tumor or throughout the course of therapy is well documented (21, 22). A blood biopsy may represent more accurate determination of the tumor's genetic features than archival DNA specimen. Adequate tissue specimens can be difficult to obtain from some patients with diagnosed malignancies, particularly lung cancer. A blood biopsy may represent a less invasive and timelier means of diagnosing both standard and translational cancer mutations.

Eligibility: Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:
  -  Advanced colorectal cancer and eligible for standard KRAS testing,
  -  Advanced non-small cell lung cancer and eligible for standard EGFR testing,
  -  Advanced melanoma and eligible for standard BRAF testing,
  -  Gastrointestinal stromal tumors (GISTs) eligible for standard c-KIT and PDGFRA testing,
  -  Being considered for potential eligibility in clinical trial.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer

Summary: The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Detailed description: patients with primary non-small cell lung cancer who received first chemotherapy in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

Eligibility: Inclusion Criteria:
  -  Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology. patients has only lung cancer .
  -  Functional Status Score (PS) ≧ 70.
  -  The first time for chemotherapy .
  -  A Written Informed Consent.
  Exclusion Criteria:
  -  Merging other tumors.
  -  HAve autoimmune diseases.
  -  AIDS

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

Summary: This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
  NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for EGFR and KRAS.
  Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+ NSCLC patients. This is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined.
  The study will enable real-life Heath Economics and Outcome Research (HEOR).
  Approximately 90 patients will be recruited. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed locally advanced or metastatic NSCLC
  -  Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform
  -  Planned first or second-line treatment with crizotinib
  -  Signed and dated IRB-approved informed consent document
  -  Ability to read and understand English or French
  -  18 years of age or older

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Summary: This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only.
  -  Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
  -  Age ≥ 18 years
  -  Able and willing to give written informed consent
  -  WHO performance status of 0 or 1 (part A and B)
  Exclusion Criteria:
  -  Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
  -  History of another primary malignancy
  -  Symptomatic or untreated leptomeningeal disease
  -  Symptomatic brain metastasis
  -  History of interstitial lung disease or pneumonitis
  -  Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
  -  Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
  -  Patients with left ventricular ejection fraction (LVEF) < 50%

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

Summary: BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.


Eligibility: Inclusion Criteria:
  -  Males or females at least 18 years of age
  -  Diagnosis of NSCLC with locally advanced or metastatic disease
  -  Positive for KRAS mutation or Squamous cell histology
  -  Previously treated with one platinum-based chemotherapy
  -  Disease status must be that of measurable and/or evaluable disease
  -  Performance status of 0 to 1 on the ECOG Scale
  -  Prior chemotherapy completed at least 3 weeks prior to study enrollment
  -  Prior radiation therapy allowed to < 25% of the bone marrow
  -  Patient compliance and geographic proximity that allow adequate follow-up
  -  Adequate organ function
  -  Patients with reproductive potential must use contraceptive methods
  -  Signed informed consent from patient
  Exclusion Criteria:
  -  Active infection
  -  Pregnancy or planning to become pregnant
  -  Breast feeding
  -  Serious concomitant systemic disorders
  -  Second primary malignancy
  -  Patients who are symptomatic from brain metastasis
  -  Presence of detectable (by physical exam) third-space fluid collections
  -  More than 1 prior cytotoxic chemotherapy regimen for advanced disease
  -  Prior treatment with docetaxel
  -  History of severe hypersensitivity reaction to polysorbate 80
  -  Peripheral neuropathy at study entry
  -  Patients known to be HIV positive
  -  Patients known to be seropositive for hepatitis C hepatitis B
  -  Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer

Summary: The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.

Detailed description: Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.
  Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.

Eligibility: Inclusion Criteria:
  1. clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
  2. T≤2cm，N0，M0.
  3. aged 60 to 80 years old.
  4. ECOG≤2.
  5. according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
  6. voluntary participation, signed informed consent.
  Exclusion Criteria:
  1. pathologic stage is N1, N2, or M1a.
  2. received postoperative adjuvant therapy (chemotherapy or targeted therapy).
  3. radiotherapy or chemotherapy before surgery.
  4. small cell lung cancer
  5. benign lesions
  6. patient unwilling to cooperate with surgery or observation.

Relevance to patient case: not relevant