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

Clinical trial: LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

Summary: The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

Detailed description: The LUMINIST study will enrol patients who are ineligible for the SELECT-1 (NCT01933932) or SELECT-2 (NCT01750281)RCTs. Within this NIS patients will be followed longitudinally for treatment information and outcomes. The final dataset will enable linkage at the individual patient level of the clinical information datasets collected within LUMINIST to the exploratory biomarker data generated from samples collected as part of SELECT-1 screening. This will enable the examination of various molecular markers in patients with v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type and some KRAS mutation positive (KRAS+) patients. The LUMINIST study aims to enable the investigation of various molecular segments in NSCLC, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. The availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. The determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations
  2. Female and male adults (according to each country regulations for age of majority)
  3. Patients who are not eligible or choose not to enter selumetinib SELECT-1 or SELECT-2 trials
  4. Patients with confirmed histological diagnosis of NSCLC
  Exclusion Criteria:
  1. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)

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

Clinical trial: Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)

Summary: The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.

Detailed description: This is a prospective and retrospective study of a population of patients with mutated non-small cell lung cancer in the Nord Pas de Calais. Retrospective cohort will involve patients with main molecular abnormalities, identifiable from molecular biology platform CRRC, except EGFR and KRAS treated from September 2011 to February 2013.

Eligibility: Inclusion Criteria:
  -  Aged ≥ 18 years old
  -  Patient with non-small cell lung cancer
  -  Detected in the Nord Pas de Calais
  -  Monitored in the Nord Pas de Calais
  -  Patient must have signed a non-opposition form to the use of medical data
  Exclusion Criteria:
  - No identified mutation

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

Clinical trial: Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

Summary: This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of advanced 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 wildtype (defined as absence of mutations in exon 9 and 20)
  -  Able and willing to give written informed consent
  -  Able and willing to undergo blood sampling for PK and PD analysis
  -  Life expectancy >=3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
  -  WHO performance status of 0 or 1.
  -  Able and willing to undergo a tumor biopsies prior to start, after two weeks (part A only) and upon progression of disease
  -  Measurable disease according to RECIST 1.1
  -  Adequate organ system function measured by laboratory values
  Exclusion Criteria:
  -  Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
  -  History of another malignancy Exception PART A: Patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible. Exception PART B: Adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin. 3. Symptomatic or untreated leptomeningeal disease.
  -  Symptomatic brain metastasis.
  -  Patients previously treated with any drug combination known to interfere with EGFR, HER2, HER3, HER4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK.
  -  History of interstitial lung disease or pneumonitis
  -  Radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
  -  Opthalmological diseases
  -  Patients with left ventricular ejection fraction (LVEF) < 55%
  -  Patients with cardiac comorbidities
  -  Concomitant or recent use (in the past 14 days) of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP3A4, 3A5 and P-glycoprotein (P-gp)

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

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

Clinical trial: A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)

Summary: This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  Tumor accessible for biopsy by bronchoscopy
  -  Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy
  Exclusion Criteria:
  -  Unstable systemic disease
  -  Any other malignancies in the last 5 years
  -  Brain metastases
  -  Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis

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

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

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

Clinical trial: A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Summary: To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.


Eligibility: Inclusion Criteria:
  -  Patients must have advanced or metastatic NSCLC or melanoma
  -  Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (melanoma) in tumor tissue
  -  All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  Exclusion Criteria:
  -  Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. BRAF mutant patients group: Prior treatment with an ERKi and/or a pan-RAFi.
  -  History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  -  Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
  -  Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
  -  Patients with Gilbert's syndrome or other heritable diseases of bile processing.
  Other protocol-defined inclusion/exclusion criteria may apply

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

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

Clinical trial: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors

Summary: The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.

Detailed description: This study has been designed as a Phase I, open-label, dose finding study with a dose escalation part and a dose expansion part in adult patients with selected advanced solid tumors. The study treatment, TNO155, will be taken until the patient experiences unacceptable toxicity, progressive disease and/or treatment is discontinued at the discretion of the investigator or the patient or due to withdrawal of consent. Some patients will be participating in a food effect investigation as an exploratory objective.

Eligibility: Inclusion Criteria:
  1. Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements.
  2. Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria.
  3. Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or is appropriate.
  4. ECOG (Eastern cooperative oncology group) performance status ≤2
  Exclusion Criteria:
  1. Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12C CRC and KRAS G12C NSCLC)
  2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  3. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
  4. Clinically significant cardiac disease.
  5. Active diarrhea or inflammatory bowel disease
  6. Insufficient bone marrow function
  7. Insufficient hepatic and renal function.

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

Clinical trial: Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

Summary: The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed description: Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Eligibility: Inclusion Criteria:
  -  Brazilian patients with metastatic non-small cell lung cancer.
  Exclusion Criteria:
  -  Small cell lung cancer and non-metastatic patients.

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

Clinical trial: Kinetics of Perioperative Circulating DNA in Cancer Surgery

Summary: The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.


Eligibility: Inclusion Criteria:
  -  The patient must have given their free and informed consent and signed the consent form
  -  The patient must be a member or beneficiary of a health insurance plan
  -  The patient is aged between 18-75
  -  Patient must weigh >40kg
  -  The patient will receive adjusted carcinological surgery
  -  Indication of curative surgery
  -  The patient has already undergone tumoral biopsy prior to surgery
  -  The patient has stage M0 cancer of either colon (right or left colonic adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma)
  Exclusion Criteria:
  -  The subject is in a period of exclusion determined by a previous study
  -  The patient is under safeguard of justice
  -  The subject refuses to sign the consent
  -  It is impossible to give the subject informed information
  -  The patient is pregnant, parturient or breast feeding
  -  Chronic alcoholism
  -  The patient has received radiotherapy or chemotherapy periopratively
  -  Cancer other than colon, breast or prostate
  -  The patient has currently or in the past, had a cancerous lesion
  -  Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy)
  -  Emergency cancer surgery

Relevance to patient case: not relevant