araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies

Summary: The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).


Eligibility: Inclusion Criteria:
  -  Measurable metastatic disease or locally advanced and unresectable disease
  -  Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy
  -  Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 prior lines of systemic therapy
  -  Has histopathologically or cytologically confirmed HCC, Child-Pugh Class A, with documented disease progression during or after discontinuation of sorafenib therapy, or intolerance of sorafenib therapy, and an α-fetoprotein (AFP) ≥ 1.5x upper limit of normal
  -  Availability of tumor tissue for biomarker analysis
  -  Has an Eastern Cooperative Oncology Group Performance Status of 0 or 1
  -  Has adequate organ function
  Exclusion Criteria:
  -  Has known brain metastases
  -  Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years
  -  History of allogeneic organ transplant
  -  Has active or prior documented autoimmune disease within the past 24 months
  -  Has human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness, or a history of immunodeficiency
  -  Has active hepatitis B or hepatitis C infection, or co-infection with both hepatitis B and C virus
  -  For gastric/GEJ and NSCLC participants, has chronic hepatitis B or hepatitis C infection. (For HCC participants, those with chronic hepatitis B virus [HBV] infection with a negative HBV deoxyribonucleic acid [DNA] test and who are on antiviral therapy, and those with chronic hepatitis C virus [HCV] infection are eligible)
  -  Has a history of interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis, non-infections pneumonitis, radiation-induced or drug-induced pneumonitis
  -  Has received any previous systemic therapy targeting programmed death (PD) 1 or PD-ligand 1/2 signaling pathways, and other immune checkpoint inhibitors
  -  Have received previous systemic therapy with ramucirumab

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

Summary: This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

Detailed description: This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
  All patients received five cycles of weekly docetaxel and cisplatin, each of 1 day's duration. Thoracic RT includes the delivery of 65 Gy in 25 fractions on weekdays for a total of five weeks.
  Nimotuzumab group was treated with five doses of weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while placebo group was treated with five doses of placebos.
  150 patients are needed to be enrolled for an 80% power to detect an improvement in overall survival from 15 months to 25 months.

Eligibility: Inclusion Criteria:
  -  histologically confirmed squamous cell lung cancer
  -  patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  -  unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI
  -  ECOG performance status 0-1
  -  Previously treated with chemotherapy or treatment-naive
  -  no previous chest radiotherapy, immunotherapy or biotherapy.
  -  hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
  -  serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
  -  bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
  -  FEV1 >0.8 L
  -  CB6 within normal limits
  -  patients and their family signed the informed consents
  Exclusion Criteria:
  -  adenosquamous carcinoma
  -  previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
  -  contraindication for chemotherapy
  -  women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
  -  women who has the probability of pregnancy without contraception
  -  tendency of hemorrhage
  -  in other clinical trials within 30 days
  -  addicted in drugs or alcohol, AIDS patients
  -  uncontrollable seizure or psychotic patients without self-control ability
  -  severe allergy or idiosyncrasy
  -  not suitable for this study judged by researchers

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)

Summary: This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed extensive-stage SCLC
  -  Disease control after the first line platinum/etoposide treatment
  -  ECOG performance status of 0 or 1
  -  Measurable disease according to RECIST Version 1.1 criteria
  -  Adequate bone marrow, liver, and renal function.
  -  Formalin Fixed Paraffin Embedded (FFPE) or frozen tumor tissue material must be available.
  -  Resolution of any toxic effects of prior therapy according to NCI CTCAE, v 4.0
  -  Full recovery from significant complications of the surgery
  -  If childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy
  -  Negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential
  -  Signed informed consent prior to beginning protocol specific procedures
  -  Patients must be available for treatment and follow-up
  Exclusion Criteria:
  -  Previous therapies with Tivantinib or other known c-MET inhibitor
  -  Radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study
  -  Palliative radiotherapy within 2 weeks prior to the inclusion in the study
  -  History of malignancy in the past five years, excluding basal cell the cervix, prostate cancer with a value of prostate-specific antigen <0.2 ng / mL
  -  History of cardiac disease
  -  Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections
  -  Pregnant or lactating women or childbearing/reproductive potential not using adequate contraception
  -  Need for breastfeeding during or within 12 weeks of completion of the study
  -  Gastrointestinal disorders that may interfere with the absorption of Tivantinib
  -  Inability or unwillingness to swallow the complete doses of Tivantinib
  -  Any known contraindication to treatment and other significant comorbid conditions which could jeopardize participation in the study

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer

Summary: There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
  The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.

Detailed description: There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.
  Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study

Eligibility: Inclusion Criteria:
  -  patients with NSCLC undergoing diagnostic
  -  Performance status 0,1,2
  Exclusion Criteria:
  -  >75 years
  -  OSA known and in the last 12 months treated PS >2
  -  Patients under a long-term oxygen therapy
  -  persons deprived of liberty by judicial decision.
  -  <18 years

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors

Summary: Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer.

Detailed description: The study will screen approximately 100 patients in order to have a total of approximately 80 evaluable patients in 5 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab.
  This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab in combination with first line chemotherapy regimens in patients with locally advanced or metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer.

Eligibility: Inclusion Criteria:
  1. Age ≥18 years at the time of screening 2. Written informed consent and any locally required authorization 4. Patients with histologically or cytologically documented chemotherapy-naive locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, and gastric cancer/GEJ.
  4a. SCCHN patients who are candidates for definitive chemoradiation are not eligible to participate.
  4b. Gastric/GEJ cancer is defined as HER-2 negative adenocarcinoma (not eligible for anti-HER-2 therapy).
  5. ECOG performance status of 0 or 1 6. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline 7. No prior exposure to immune-mediated therapy 8. Adequate organ and marrow function
  Exclusion Criteria:
  1. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment
  2. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment
  3. Any unresolved Grade ≥2 toxicity from previous anticancer therapy
  4. Active or prior documented autoimmune or inflammatory disorders
  5. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study drugs, or compromise the ability of the patient to give written informed consent
  6. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms 20. Active tuberculosis
  7. Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Use of [18]F-FDG on PET/CT as an Alternative Non-invasive Method for Staging of Lung Cancer

Summary: To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for staging of non-small cel lung carcinoma.

Detailed description: The main aim of this study is to validate the [18F]FDG on PET/CT for the diagnosis of metastatic ganglions at the mediastinum in SUS patients with non-small cell lung carcinoma considering sensitivity, specificity, positive predictive value, negative predictive value, accuracy. Other specific aims are:
  -  Analyze the diagnosis performance of the [18F]FDG on PET/CT in two timepoints (1 and 2 hours after exam), in relation to the staging of the non-small cell lung carcinoma
  -  Evaluate the addition of the iodinated contrast in the [18F]FDG to improve the images obtained from the PET/CT in the staging of the non-small cell lung carcinoma

Eligibility: Inclusion Criteria:
  1. Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma
  2. Patients who previously underwent staging of the disease with CT
  3. Clinical stages I-III AJCC 7th edition.
  4. Patients with indication for mediastinoscopy and linfonodal biopsy
  5. Patients without treatment for lung cancer
  6. Patients with biochemical and haematological exams
  7. Women of childbearing potential using contraceptive methods and negative pregnancy test
  8. Adults with more than 18 years old.
  9. Both genders
  Exclusion Criteria:
  -  Pregnant women
  -  Patients with other types of patients

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.

Detailed description: Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.
  Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.

Eligibility: Inclusion Criteria:
  -  Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
  -  The Karnofsky performance status (KPS) score ≥70.
  -  The expected survival time ≥3 months.
  -  Adequate blood, liver, lungs and kidney function
  -  Accessible contact information
  -  Informed consent required before enrollment.
  Exclusion Criteria:
  -  Pregnant or breastfeeding.
  -  Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years)
  -  Cannot receive concurrent chemotherapy due to medical reasons.
  -  Superior vena cava syndrome.
  -  Severe lung diseases that affected lung function.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?

Summary: Not significantly increased survival in T/T


Eligibility: Inclusion Criteria:
  -  NSCLC with spinal metastasis
  Exclusion Criteria:
  -  brain metastasis and expected survival < 3 months

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung

Summary: uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Detailed description: Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.
  Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.

Eligibility: Inclusion Criteria:
  Study I
  -  Histologically verified NSCLC (Study I)
  -  Stage IV disease
  -  Operable disease
  -  The participants must be capable of understanding and giving full informed written consent
  Study II
  -  Histologically verified MPM (Study II)
  -  The participants must be capable of understanding and giving full informed written consent
  Study III
  -  Histologically verified LCNEC (Study III)
  -  The participants must be capable of understanding and giving full informed written consent
  Exclusion Criteria:
  Study I, II, III
  -  Pregnancy
  -  Lactation/breast feeding
  -  Treatment with neoadjuvant chemotherapy
  -  Weight above 140 kg
  -  Allergy to 68Ga-NOTA-AE105

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer

Summary: A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)


Eligibility: Inclusion Criteria:
  -  non small cell lung cancer
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study CB-839 in Combination With Nivolumab in Patients With ccRCC and Other Solid Tumors

Summary: This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.

Detailed description: This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.
  During Phase 1, patients will be enrolled into escalating dose cohorts to determine the recommended phase 2 dose (RP2D).
  In Phase 2, patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer will be enrolled into separate cohorts.
  All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.

Eligibility: Addition eligibility criteria based on tumor type apply
  Inclusion Criteria:
  -  Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
  -  Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  -  Life Expectancy of at least 3 months
  -  Adequate hepatic, renal, cardiac, and hematologic function
  -  Measurable disease by RECISTv1.1 criteria
  -  Resolution of treatment-related toxicities except alopecia
  Exclusion Criteria:
  -  Unable to receive oral medications
  -  Unable to receive oral or IV hydration
  -  Intolerance to prior anti-PD-1/PD-L1 therapy
  -  Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)
  -  Any other current or previous malignancy within 3 years except protocol allowed malignancies
  -  Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
  -  Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: Some cohort exceptions allow anti-PD-1 therapy)
  -  Active known or suspected exclusionary autoimmune disease
  -  Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks
  -  History of known risks factors for bowel perforation
  -  Symptomatic ascites or pleural effusion
  -  Major surgery within 28 days before Cycle 1 Day 1
  -  Active infection requiring within 2 weeks prior to first dose of study drug
  -  Patients who have HIV, Hepatitis B or C
  -  Conditions that could interfere with treatment or protocol-related procedures
  -  Active, non-stable brain metastases or CNS disease

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

Summary: The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.


Eligibility: Inclusion Criteria - Primary Study Cohort
  -  Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)
  -  Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  -  Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC
  -  Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period
  Inclusion Criteria - Secondary Study Cohort
  -  Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)
  -  Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  -  Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M).
  Exclusion Criteria - Primary and Secondary Study Cohorts
  • Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.

Relevance to patient case: definitely relevant