araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Food Reward in Cachexia Induced by Acute or Chronic Disease

Summary: To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.

Detailed description: The activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. In addition, the role of the peripheral satiety hormones will be evaluated.

Eligibility: Inclusion Criteria:
  -  For cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or >2% when body mass index is <20 kg/m2
  -  For non-cachectic patients: no weight loss of ≥5% during the last 6 months
  -  Non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
  Exclusion Criteria:
  -  Contra-indications for fMRI examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; Pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up)
  -  Psychiatric or other disorders likely to impact on informed consent
  -  Presence of brain metastasis (screening is not mandatory)
  -  Medical history of cerebrovascular accident, brain tumour, brain metastasis
  -  Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy
  -  Memory problems
  -  Current use of tube feeding or parental nutrition
  -  Patients with an active second malignancy
  -  Patients unable to lie still for 2 hours
  -  Unable to complete the cognitive task
  -  Pre-existing swallowing difficulties
  -  Allergy to gluten-, milk- or wheat products
  -  Self-reported hyperthyroidism
  -  Self-reported diabetes mellitus
  -  Current use of appetite stimulant medications

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery

Summary: This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation lung cancer.

Detailed description: Selected patients will receive 4 weeks of gefitinib before surgery. A Positron Emission Tomography - Computed Tomography (PET- CT) will be performed before and after gefitinib to assess the response. Circulating tumour cells (CTCs) and plasma Deoxyribonucleic acid (DNA) will be acquired at baseline, 2 weeks and 4 weeks after gefitinib treatment. Resected tumor will be sectored in details to study the spatial heterogeneity.

Eligibility: Inclusion Criteria:
  -  EGFR mutation positive Non-Small Cell lung cancer (NSCLC) (regardless of smoking status), or control group may encompass other molecular subtypes of lung cancer e.g. anaplastic lymphoma kinase (ALK) and Kirsten rat sarcoma viral oncogene homolog (KRAS).
  -  All early stage patients with NSCLC who are deemed surgically resectable.
  -  All patients must have histologically proven NSCLC, with known EGFR mutation
  -  Patients should be fit for either lobectomy/ pneumonectomy with or without lymph node sampling.
  -  Primary tumour should be at least 2 cm in size (Tumor stage 1b).
  -  Willing to provide informed consent.
  Exclusion Criteria:
  -  Known severe hypersensitivity to gefitinib or any of the excipients of this product
  -  Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  -  Interstitial lung disease (ILD) or pulmonary fibrosis; impaired pulmonary function
  -  Patients with prior exposure to agents directed at the Human epidermal receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  -  Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
  -  Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  -  Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
  -  Patient who has serious active infection.
  -  Patients who harbouring exon 20 T(Threonine)790M (Methionine) mutation.
  -  Pregnancy or breast feeding.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Summary: Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
  -  Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
  -  ECOG performance status 0 to 2.
  -  Adequate organ function
  -  Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
  -  Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.
  Exclusion Criteria:
  -  Currently receiving crizotinib or any investigational products.
  -  Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
  -  Carcinomatous meningitis or leptomeningeal disease.
  -  Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
  -  Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
  -  Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
  -  History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
  -  Pregnant female patients; breastfeeding female patients.
  -  Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices

Relevance to patient case: definitely relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer

Summary: This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.


Eligibility: Key Inclusion Criteria:
  -  Must have histologically or cytologically confirmed non-squamous NSCLC.
  -  Must have progressed following treatment with platinum-based combination chemotherapy for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted treatment.
  -  Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated
  -  Weekly paclitaxel must be an acceptable treatment option
  -  Must submit tumor tissue for correlative analyses
  -  Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
  -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and a life expectancy of ≥ 3 months
  Key Exclusion Criteria:
  -  Has squamous NSCLC
  -  Has received prior systemic treatment with a taxane for advanced/metastatic disease
  -  Has received systemic anti-cancer therapy within the 14 days prior to randomization
  -  Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
  -  Has brain metastases with evolving neurologic symptoms or a steroid requirement.
  -  Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
  -  Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
  -  Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)
  -  Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
  -  Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery for Recurrent Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

Detailed description: Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.
  In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility: Inclusion Criteria:
  -  Age ≤ 75 years with histologically proven NSCLC
  -  No severe major organ dysfunction
  -  WHO performance status of 0 or 1
  -  No prior cancer chemotherapy
  -  A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
  Exclusion Criteria:
  -  Age ≥ 76
  -  Severe major organ dysfunction
  -  WHO performance status of >1
  -  Prior cancer chemotherapy
  -  Stage IV

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

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: definitely relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Transbronchial Ablation for Peripheral Lung Cancer

Summary: The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for the treatment of early-stage inoperable peripheral lung cancer.

Detailed description: The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for treating inoperable patients with early-stage non-small cell lung cancer . The study is designed as a single-center prospective trial. The participating centers are Department of pulmonary medicine and endoscope, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, China. Patients are divided into two groups, including radiofrequency ablation group and microwave ablation group.Eighty patients are expected to be enrolled into the study with 40 patients in each group.

Eligibility: Inclusion Criteria:
  1. Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA.
  2. The tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 8mm and no more than 30mm.
  3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
  4. Patients have good compliance and sign the informed consent.
  Exclusion Criteria:
  1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
  2. Patients have contraindications of general anesthesia.
  3. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
  4. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion.
  5. There are large blood vessels or important structures adjacent to peripheral lung lesion.
  6. Researchers consider the patient do not fit for the study.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

Summary: The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.

Detailed description: The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.

Eligibility: Inclusion Criteria:
  -  Individuals who have been diagnosed with lung cancer (survivor) or
  -  Caregiver of a participating lung cancer survivor
  -  Ability to read and write in English
  Exclusion Criteria:
  -  Individuals with significant psychiatric disturbance that requires a higher level of care
  -  Individuals with substance abuse/dependence problem that require a higher level of care
  -  Incarcerate individuals or individuals detained within the legal system

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics

Summary: To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility: Inclusion Criteria:
  -  Histological documentation of Advanced solid tumors
  -  Lack of the standard treatment or treatment failure
  -  18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
  -  Main organs function is normal
  -  Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  -  Patients should participate in the study voluntarily and sign informed consent
  Exclusion Criteria:
  -  Patients with treatment failure by ALK/ROS1 inhibitor
  -  Patients with anti-teratment,radiotherapy or surgery within 4 weeks
  -  Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week
  -  Blood pressure unable to be controlled(systolic pressure>140 mmHg，diastolic pressure>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
  -  Patients with non-healing wounds or fractures
  -  Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  -  History of immunodeficiency
  -  Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Relevance to patient case: not relevant