araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer

Summary: The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.

Detailed description: The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.
  The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Eligibility: Inclusion Criteria:
  -  Advanced NSCLC that cannot undergo curative surgery.
  -  Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
  -  Histologically diagnosed NSCLC.
  -  Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
  -  ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
  -  Life expectancy > 3 months.
  -  Age between 20 to 79
  -  Male or Female.
  -  In patients or out patients.
  -  Able and willing to give valid written informed consent.
  Exclusion Criteria:
  -  Other malignancy requiring treatment
  -  radiation, immunotherapy, hyperthermia, or surgery.
  -  Active and uncontrolled infectious disease
  -  Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
  -  Autoimmune disease.
  -  HIV-Ab or antigen positive
  -  Prior anti-cancer therapy within 4 weeks
  -  Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value.
  -  Patients knows HLA-A type.
  -  Breastfeeding and Pregnancy (woman of child bearing potential)
  -  Refusal of pregnancy conception.
  -  Treated with S-488401, S-488402, or S-488403.
  -  Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
  -  Decision of nonenrollment 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: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Summary: In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.
  There is two types of maintenance strategies:
  -  Continuous maintenance : prolongation of the treatment initially associated with platin until progression
  -  Switch maintenance : introduction of a new treatment after the end of induction chemotherapy
  The aim of this study is to compare two maintenance strategies
  -  A continuous maintenance by pemetrexed
  -  A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.


Eligibility: Inclusion Criteria:
  -  Non-squamous NSCLC histologically or cytologically confirmed
  -  Stage IV with a cytologically or histologically confirmation for an unique metastasis
  -  No EGFR activating mutation or indeterminate EGFR mutational status
  -  At least one measurable lesion
  -  Age between 18 and 70
  -  PS 0 or 1
  Exclusion Criteria:
  -  squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
  -  Knowledge of ALK gene rearrangement
  -  Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy
  -  Superior venous cave syndrome except if treated by implantation of a prosthesis
  -  Previous anti-tumoral treatment
  -  Concomitant radiotherapy

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Circulating Tumor Cells in Lung Cancer

Summary: TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)
  BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.
  PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).
  SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.
  STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.
  Duration of the inclusions: 54 months.
  Duration of the study: 66 months.
  PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.
  SAMPLE SIZE : 200 patients
  STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.


Eligibility: Inclusion Criteria:
  -  Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
  -  Age ≥ 18 years.
  -  Measurable or evaluable disease according to RECIST criteria.
  -  Ability to sign informed consent.
  Exclusion Criteria:
  -  Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
  -  Prior chemotherapy, radiation or surgery for lung cancer.
  -  Inability to comply with study and/or follow-up procedures.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.


Eligibility: Inclusion Criteria:
  -  Non-Small Cell Lung Cancer disease
  -  Clinical stage IV or recurrent disease
  -  One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy
  -  For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization
  -  For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1
  -  Adequate organ function
  -  Estimated life expectancy of at least 3 months.
  Exclusion Criteria:
  -  Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment
  -  Receiving concurrent treatment with other anticancer therapy
  -  Central nervous system disease other than stable and treated brain metastasis
  -  Has major blood vessel invasion or encasement by cancer
  -  Has intratumor cavitation
  -  Has a history of uncontrolled thrombotic disorder
  -  Is receiving therapeutic anticoagulation with drugs
  -  Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs
  -  Has a history of hemoptysis within 2 months prior to randomization
  -  Has clinically relevant congestive heart failure
  -  Has experienced any arterial thromboembolic event
  -  Has uncontrolled arterial hypertension
  -  Has had a serious or nonhealing wound or, ulcer
  -  Has significant existing conditions

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer

Summary: Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.

Detailed description: Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.

Eligibility: Inclusion Criteria:
  Preoperative criteria:
  i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
  (4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
  (5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.
  Exclusion Criteria:
  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) double cancers.
  3. Women during pregnancy or breast-feeding.
  4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
  5. Psychosis.
  6. Systemic steroids medication.
  7. Uncontrollable diabetes mellitus.
  8. Uncontrollable hypertension.
  9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer

Summary: We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.


Eligibility: Inclusion Criteria:
  -  Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage
  -  Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.
  -  The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.
  -  Karnofsky performance status was ≥ 80.
  -  Forced expiratory volume at 1 second (FEV1) ≥ 1 L.
  -  Had measurable or assessable disease.
  -  Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.
  -  Serum creatine and bilirubin < 1.5 × the upper normal limit (UNL), aminotransferase < 2 × UNL.
  -  Weight loss was less than 10% within 6 months before diagnosis.
  -  Written informed consent was required from all patients.
  Exclusion Criteria:
  -  Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Morbidity and Mortality Follow Up for the Scleroderma Lung Study

Summary: The primary intent of this study is to add to the body of knowledge on scleroderma patients with interstitial lung disease. While lung disease is recognized as the leading cause of death amongst patients with scleroderma, there is not a large body of literature describing the long-term morbidity and mortality rate of these scleroderma patients. For this reason, the investigators are following participants of the Scleroderma Lung Study (NCT00004563) after their participation in that study was concluded. In addition, the investigators will assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung Study experienced progression of their scleroderma-related lung disease following the end of the study.

Detailed description: Retrospective and prospective data will be collected about patients who participated in the Scleroderma Lung Study (SLS). An attempt will be made to include all of the participants of the Scleroderma Lung Study, who were reported as alive at the end of that study.
  A total of 158 subjects (79 per treatment arm) were randomized on the original Scleroderma Lung Study. Of those, 109 subjects completed the study. A single telephone interview with the participants to assess the occurrence of severe events and a review of the participant's medical records may be conducted. The outcome information will be combined with information collected about all participants in the SLS study. The data being collected includes information on mortality, development of cancers, development of organ failure, and performance status.

Eligibility: Inclusion Criteria:
  -  Participation in the Scleroderma Lung Study

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Phase I Study of iPS Cell Generation From Patients With COPD

Summary: As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.


Eligibility: Inclusion Criteria:
  -  Undergoing Thoracic Surgery at the Mayo Clinic Rochester
  -  Presence of a Thoracic Disease

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Summary: Efficacy of Dovitinib for Squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  histologically confirmed squamous NSCLC
  -  Previously treated with one or two lines of chemotherapy
  -  FGFR amplification (FISH > 5 copies of genes)
  -  20 years or older
  -  ECOG PS 0-2
  Exclusion Criteria:
  -  active infection
  -  uncontrolled brain metastasis
  -  unstable angina or MI

Relevance to patient case: definitely relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: CT in Diagnosing Patients With Lung Cancer

Summary: This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.
  II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.
  III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.
  OUTLINE:
  Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

Eligibility: Inclusion Criteria:
  -  Measurable disease on CT scan
  -  Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
  -  Patients must be able to perform ABC procedures
  Exclusion Criteria:
  -  Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
  -  No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
  -  Women of childbearing potential will undergo a pregnancy test

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)

Summary: To study the NSCLC evolutionary genomic landscape between primary and metastatic sites and the dynamics of intratumour heterogeneity over time combined with detailed clinical, histopathological and cancer phenotypic annotation for each patient, in order to significantly improve the outcomes of NSCLC patients (e.g. reduce their chance of recurrence and improve survival).

Detailed description: The importance of intratumour genetic and functional heterogeneity is increasingly recognised as a driver of cancer progression and survival outcome. Understanding how tumour clonal heterogeneity impacts upon therapeutic outcome, however, is still an area of unmet clinical and scientific need. TRACERx (TRAcking non-small cell lung Cancer Evolution through therapy [Rx]), a prospective study of patients with primary non-small cell lung cancer (NSCLC), aims to define the evolutionary trajectories of lung cancer in both space and time through multiregion and longitudinal tumour sampling and genetic analysis. By following cancers from diagnosis to relapse, tracking the evolutionary trajectories of tumours in relation to therapeutic interventions, and determining the impact of clonal heterogeneity on clinical outcomes, TRACERx may help to identify novel therapeutic targets for NSCLC and may also serve as a model applicable to other cancer types.

Eligibility: Inclusion Criteria:
  -  Written Informed consent
  -  Patients ≥18 years of age, with early stage I-IIIA disease who are eligible for primary surgery
  -  Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g. diagnosis determined from frozen section in theatre)
  -  Primary surgery in keeping with NICE guidelines planned (see section 9.3)
  -  Agreement to be followed up in a specialist centre
  -  Performance status 0 or 1
  -  Suspected tumour at least 15mm in diameter on pre-operative imaging
  Exclusion Criteria:
  -  Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
  -  Psychological condition that would preclude informed consent
  -  Treatment with neo-adjuvant therapy for current lung malignancy deemed necessary
  -  Adjuvant therapy other than platinum-based chemotherapy and/or radiotherapy
  -  Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
  -  Sufficient tissue, i.e. a minimum of two tumour regions, is unlikely to be obtained for the study based on pre-operative imaging.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Treatment of Multifocal Lung Adenocarcinoma

Summary: To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

Detailed description: Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.

Eligibility: -  Patient must be > 18 years of age
  -  Two or more GGO's or solid lesions suspicious for multifocal disease.
  -  Clinical diagnosis of N0
  -  No evidence of distant metastases
  -  No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC).
  -  No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin.
  -  PFT's that show patient is capable of tolerating a lung resection.
  -  Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
  -  Patient must be able to understand and willing to sign an IRB-approved informed consent document.

Relevance to patient case: not relevant