araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

Summary: This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.


Eligibility: Inclusion Criteria:
  -  Adult participants, ≥ 18 years of age.
  -  Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
  -  Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
  -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
  -  European Cooperative Oncology Group (ECOG) performance status ≤ 2.
  Exclusion Criteria:
  -  Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
  -  Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
  -  Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
  -  Any inflammatory changes of the surface of the eye.
  -  ≥ Grade 2 peripheral neuropathy.
  -  History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
  -  Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
  -  Human immunodeficiency virus (HIV) infection.
  -  Pregnant, nursing, or lactating women.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.
  Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  Histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis

Summary: Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.

Detailed description: Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring > 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib

Eligibility: Inclusion Criteria:
  -  Patients must have signed a written informed consent form prior to any study specific screening procedures
  -  18 years or older
  -  KPS ≥ 50%
  -  Histologically confirmed adenocarcinoma of the lung
  -  Activating mutation of EGFR
  -  Newly diagnosed CNS metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion > 1 cm on T1-weighted contrast enhanced MRI)
  -  Patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except TKI.
  -  No steroids or stable or decreasing dose of steroids for at least 5 days before the MRI evaluation.
  -  Adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; Hb ≥ 9 g/Dl; Total bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN (< 5 x ULN in patients with liver metastases); Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min
  Exclusion Criteria:
  -  Prior treatment of brain metastases with WBRT or TKI
  -  Patient eligible for radiosurgery or surgical resection
  -  Contre indication at the radiotherapy
  -  Leptomeningeal disease
  -  Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry
  -  Prior treatment with Gefitinib or other TKI
  -  Pregnant or breast feeding women
  -  Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Retrospective EGFR Mutation Status Study in Chinese NSCLC Patients Using Paired Plasma and Tissue Samples

Summary: EGFR mutations plays an essential role in EGFR-TKIs treatment. However, for some patients, tissue samples are not available. The purpose of this study is to determine whether blood sample is feasible for EGFR mutation detection.For late stage NSCLC, we hypothesis plasma sample is an alternative for detecting EGFR mutations.


Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer
  -  Available plasma and pathologically confirmed tissue slices(pre-chemo and pre-radio therapy)
  -  Informed Consent
  Exclusion Criteria:
  -  N/A

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

Summary: To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Detailed description: Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.

Eligibility: Inclusion Criteria:
  1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
  2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
  3. Measurable, evaluable disease outside of a radiation port.
  Exclusion Criteria:
  1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
  2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO

Summary: To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).


Eligibility: Inclusion Criteria:
  -  Advanced Non-Small Cell Lung Cancer (NSCLC).
  -  For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
  -  For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
  -  All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  -  Estimated creatinine clearance ≥15 mL/min.
  Exclusion Criteria:
  -  Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
  -  Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
  -  Patients with known diffuse interstitial lung disease (all cohorts).
  -  Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

Summary: This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

Detailed description: Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed stage II & IIIA non-small cell lung cancer
  -  EGFR exon 19 or 21 mutations
  -  Age ≥ 18 years and ECOG performance 0~1
  -  Has measurable lesion by RECIST 1.1
  -  No previous chemotherapy or radiation therapy
  -  Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr < 1 x UNL or creatinine clearance > 60 ml/min, Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL
  -  Written informed consent form
  Exclusion Criteria:
  -  Previous chemotherapy or radiation therapy
  -  Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
  -  Known allergic history of erlotinib
  -  Interstitial lung disease or fibrosis on chest radiogram
  -  Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
  -  Pregnant or nursing women

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)

Summary: This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
  -  Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
  -  squamous cell carcinoma lung cancer histology, and
  -  current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  -  Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva
  Exclusion Criteria:
  -  Current treatment with an investigational drug or participation in another investigational study
  -  Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
  -  Clinically active interstitial lung disease
  -  Recent myocardial infarction or unstable angina
  -  Progressive or uncontrolled brain metastases

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

Summary: The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Detailed description: Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Eligibility: Inclusion Criteria:
  -  Informed consent form
  -  Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx
  -  The tumor mass had to be measurable
  -  Karnofsky performance status ≥70
  -  Life expectancy estimated than 6 months
  -  Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；
  -  Hepatic: AST/ALT＜1.5 times upper limit of normal (ULN)；serum bilirubin<1.5 times ULN;
  -  Renal: Creatinine＜1.5 times ULN；
  Exclusion Criteria:
  -  Known distant metastases
  -  Primary tumor and nodes received surgery(except of biopsy)
  -  Received other anti EGFR monoclonal antibody treatment
  -  Previous chemotherapy or radiotherapy
  -  Participation in other interventional clinical trials within 1 month
  -  Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
  -  History of serious allergic or allergy
  -  History of Serious lung or heart disease
  -  Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer

Summary: With roughly 80% of cancer patients receiving their oncology care in the community setting, the investigators are proposing to sample from a community-based center to evaluate the percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit from erlotinib and assess the clinical characteristics that are associated with erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.


Eligibility: Inclusion Criteria:
  -  Patients must have had NSCLC.
  -  Patients must have received erlotinib (single-agent) for six months or longer for NSCLC in the second/third line setting or as maintenance therapy.
  -  Patients must have tissue available for EGFR-mutation status testing (if not previously performed) or EGFR-mutation status test results available.
  -  Patients must have tissue available for exploratory genetic analysis.
  -  Patients must have all clinical information, treatment response data and outcomes data available for review.
  -  Patients must be deceased.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Summary: The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Detailed description: CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility: Inclusion Criteria:
  -  histologically confirmed metastatic colorectal adenocarcinoma
  -  KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
  -  has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
  -  ECOG performance status 0 to 1
  -  Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
  Exclusion Criteria:
  -  Previous irinotecan or anti-EGFR therapies
  -  hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
  -  liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
  -  Renal function: serum creatinine, more than 1.5 times the upper limit of normal
  -  Patients with symptomatic central nervous system metastases

Relevance to patient case: not relevant