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

Clinical trial: Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Summary: Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Detailed description: Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed Lung adenocarcinoma
  -  Wld-type EGFR
  -  Stage IIIB/IV
  -  Failure to prior chemotherapy
  -  Life expectancy of more than 3 months
  -  Tissue sample desired for genomic study
  -  Age ≥ 18 years
  -  Performance status (WHO) < 3
  -  Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
  -  Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  -  Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  -  Informed consent
  Exclusion Criteria:
  -  Have previously received pemetrexed or TKIs
  -  Other concurrent uncontrolled illness

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 Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

Summary: This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
  -  Non-small cell lung cancer with an EGFR activating mutation
  -  Patients must have evidence of disease, but measurable disease is not mandatory
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate renal and liver function
  Exclusion Criteria:
  -  Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
  -  Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
  -  Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
  -  Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
  -  Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
  -  Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
  -  Pregnant or breast-feeding 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: A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

Summary: This study will assess the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that are known to have dysregulation of the c-MET pathway and who have failed after benefiting on a prior treatment with either gefitinib or erlotinib.

Detailed description: Patients will be treated INC280 and gefitinib(250mg) daily. Dose escalation for INC280 will be performed. Each cohort for the phase IB part will consist of 3 to 6 newly enrolled patients. A twice daily administration of INC280 may be investigated if deemed appropriate based on emerging results from ongoing clinical trials.

Eligibility: Inclusion Criteria:
  -  Documented EGFR mutation
  -  Documented c-MET dysregulation
  -  Prior clinical benefit on EGFR inhibitors and then subsequent progression
  -≥ 18 year old
  -  Life expectancy of ≥ 3 months
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  -  Unable to swallow tables once or twice daily
  -  Previous treatment with c-MET inhibitor
  -  Any unresolved toxicity form previous anticancer therapy greater than grade 1
  -  History of cystic fibrosis
  -  History of acute or chronic pancreatitis
  -  Unable to undergo MRI or CT sans
  -  Known history of HIV
  -  Undergone a bone marrow or solid organ transplant
  -  Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
  -  Pregnant or nursing
  Other protocol-defined inclusion/exclusion criteria may apply

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 Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary: This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.


Eligibility: Inclusion Criteria:
  -  Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
  -  Measurable disease according to RECIST
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Life expectancy greater than or equal to (>/=) 12 weeks
  -  Adequate hematological, liver and renal function
  -  Participants with asymptomatic and stable cerebral metastases receiving medical treatment
  Exclusion Criteria:
  -  Previous chemotherapy or treatment against EGFR for metastatic disease
  -  Treatment with an investigational agent less than 3 weeks before enrollment
  -  History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
  -  Participants with symptomatic cerebral metastases
  -  Any significant ophthalmologic abnormality
  -  Unstable systemic disease
  -  Coumarins use
  -  Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
  -  Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
  -  Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)

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

Clinical trial: Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

Summary: At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
  In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
  The question is to know if this strategy is feasible in lung cancer.


Eligibility: Inclusion Criteria:
  -  Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
  -  Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
  -  Measurable disease (recist criteria)
  -  Age ≥18 years
  -  PS0 or 1
  Exclusion Criteria:
  -  Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
  -  History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
  -  Tumor invaded the big vessels or the proximal visible in TDM.
  -  History of adjuvant or neoadjuvant chemotherapy

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

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: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Summary: Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility: Inclusion Criteria:
  -  NSCLC confirmed by histopathology or cytology;
  -  Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
  -  Has active mutation of EGFR in exon 19 or 21;
  -  Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  -  expectancy life >= 12 weeks;
  Exclusion Criteria:
  -  Had be treated by HER-targeting agents;
  -  Had systemic anit-NSCLC treatments;
  -  Had local radiotherapy for NSCLC;
  -  Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  -  Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  -  Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
  -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

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

Clinical trial: Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

Summary: The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.


Eligibility: Inclusion Criteria:
  Inclusion Criteria for patients´ screening:
  -  Patients of both sexes aged 18 or more.
  -  Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
  -  Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
  -  Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
  -  Patients who have granted their written informed consent.
  Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
  Inclusion Criteria for patients´ follow-up
  -  Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
  Exclusion Criteria:
  -  Combined histology of non-small cell and small cell lung cancer.

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

Clinical trial: C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).

Summary: The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.
  New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)
  Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.
  Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.
  The purposes of the study are:
  1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
  2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.


Eligibility: Inclusion Criteria:
  -  patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
  -  patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.
  Exclusion Criteria:
  -  lack of histological diagnosis;
  -  not a candidate for erlotinib;
  -  pregnancy.

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

Clinical trial: Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

Summary: The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Detailed description: This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Eligibility: Inclusion Criteria:
  -  Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  -  Positive EGFR Mutation.
  -  No previous systemic anticancer therapy.
  -  Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  -  Provision of written informed consent.
  Exclusion Criteria:
  -  Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  -  Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product.
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

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

Clinical trial: ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

Summary: This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
  -  EGFR mutation-positive disease according to local laboratory testing
  -  Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice
  Exclusion Criteria:
  -  Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva
  -  Participation in another clinical study
  -  Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment

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

Clinical trial: Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer

Summary: Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Detailed description: Single arm, open label, prospective, observational study of gefitinib treatment for locally advanced (stage IIIB) or IV (metastatic) or relapsed NSCLC patients.
  Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Eligibility: Inclusion Criteria:
  -  Locally advanced stage IIIB not suitable for curative therapy or stage IV (metastatic) disease or relapsed NSCLC
  -  ECOG Performance status 0~2.
  -  Written Informed Consent
  -  Female or male patients aged 18 years or over, eligible for treatment for NSCLC
  Exclusion Criteria:
  -  Previous exposure to EGFR-TKI
  -  Concomitant use of other anti-cancer drugs with EGFR-TKI
  -  Patients without available Tumor DNA
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  -  Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

Relevance to patient case: not relevant