araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

Summary: The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.


Eligibility: Inclusion Criteria:
  1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
  2. No previous systemic anticancer therapy.
  3. life expectancy more than three months.
  4. ECOG Performance Status of 0 to 1.
  5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  6. Patients will be required to provide informed consent before enrollment.
  Exclusion Criteria:
  1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
  2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
  3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.
  4. Active concomitant malignancy, and pregnancy or breast-feeding.

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC

Summary: The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).


Eligibility: Inclusion Criteria:
  -  Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
  -  Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R).
  -  Mandatory provision of adequate archived stage IV NSCLC tissue sample.
  -  At least one measurable lesion.
  -  Life expectancy of at least 3 months.
  Exclusion Criteria:
  -  Known T790M EGFR mutation.
  -  Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
  -  Serious illness or medical condition.
  -  Ongoing treatment with CYP3A4 inducers or strong/moderate inhibitors.
  -  Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
  -  History of gross hemoptysis.
  -  Significant bleeding disorders.
  -  Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
  -  Radiographic evidence of intratumor cavitation.
  -  History of gastrointestinal perforation within last 6 months.
  -  History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
  -  History of any arterial thrombotic event within 6 months prior to enrollment.
  -  The participant has any known significant ophthalmologic abnormalities of the surface of the eye.

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Anticancer Activity of Nicotinamide on Lung Cancer

Summary: Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer cells. Nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.

Detailed description: The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). To determine the effectiveness of nicotinamide on lung cancer, nicotinamide or placebo tablet will be co-administered with gefitinib or erlotinib for two years until the event or censoring occurs. The stratified block randomization was designed with 3 covariates (EGFR mutation status, kind of EGFR-TKI, ECOG (Eastern Cooperative Oncology Group) performance status score variation). The size of lesions will be checked every other months by radiology. PD (progressive disease) will be assessed according to RECIST(Response Evaluation Criteria in Solid Tumors)1.1. After observing 36 events, an interim analysis of hazard ratio by Cox proportional hazard regression will be performed. The final analysis will be done by the same protocol after observation of 72 events. The significance level of the interim and final analysis were set to 0.0075 and 0.0209 respectively. Response rate, quality of life (measured by 10 questions at every visit), and overall survival will be analysed together. All other adverse reactions will be analysed and reported, if there.

Eligibility: Inclusion Criteria:
  -  Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy
  -  EGFR mutated (exon 19 deletion or L858R mutation)
  -  Life expectation more than 3 months
  -  More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously
  -  ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2
  -  Who signed the informed consent form
  Exclusion Criteria:
  -  Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy
  -  Who has metastasized brain lesion that needs operation or radiation therapy
  -  Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney
  -  Who does Not agree to contraception
  -  Who has allergy to nicotinamide

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

Summary: The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

Detailed description: An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC.
  -  Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
  -  Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
  -  Patient must be able to comply with the protocol
  Exclusion Criteria:
  -  Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
  -  Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
  -  Histologically confirmed small cell lung cancer or other metastatic tumors
  -  Patient with no histologic or cytological diagnosis.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring

Summary: The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura.
  The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.


Eligibility: Inclusion Criteria:
  -  Histologically proved lung cancer
  Exclusion Criteria:
  -  History of other cancers within the past 5 years
  -  Pregnancy or breast milk feeding
  -  TB pleuritis and peritonitis

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic NSCLC
  -  EGFR mutation (L858R and /or ex19del)
  -  cMET amplification by FISH (GCN ≥ 6),
  -  Acquired resistance to EGFR TKI (1st or 2nd génération)
  -  ECOG performance status (PS) ≤ 1.
  Exclusion Criteria:
  -  Prior treatment with 3rd generation TKI
  -  PhaseII : Prior treatment with any of the following agents:
  -  Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.
  -  Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.
  -  Platinum-based chemotherapy as first line treatment

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

Summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Detailed description: This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Eligibility: Inclusion Criteria:
  -  Age: at least 20 years of age
  -  Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
  -  Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
  -  At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
  -  World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
  -  Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
  -  At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
  -  Adequate hematological and biological function
  -  Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
  -  Male patients should be documented to be sterile or agree to use barrier contraception
  -  Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia
  Exclusion Criteria:
  -  Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
  -  Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
  -  Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
  -  Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
  -  History of any other malignancy
  -  Clinically significant uncontrolled condition(s)
  -  Active or chronic pancreatitis
  -  Anyone with cardiac abnormalities or history
  -  Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
  -  Pregnant or breast feeding
  -  In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Afatinib Genomic Landscape

Summary: The investigators propose to conduct a pilot feasibility study of single agent afatinib in patients with previously untreated metastatic EGFR (epidermal growth factor receptor) mutant adenocarcinoma of the lung (NSCLC = non-small cell lung cancer) with the sole purpose of characterizing the genomic landscape before afatinib and at the time of disease progression.

Detailed description: The current proposal will include exome and transcriptome sequencing from blood collected at baseline along with tumor samples obtained prior to starting afatinib and at the time of disease progression (a total of two tissue samples and one blood sample per patient). The samples will be collected via consent to the IRB (Institutional Review Board) approved banking study "Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma".
  If carried out successfully, the proposed strategy very likely will lead to a larger and adequately powered study (perhaps using whole genome sequencing) to understand fully evolving molecular changes due to clonal selection under treatment pressure. The pace of progress in the field of sequencing technology currently underway is only likely to accelerate in the near future yielding richer and highly content-rich information. Moreover, it is likely that genomic information from DNA sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes.
  Successful completion of the proposed study would enable future studies to fully harness the potential of emerging technologies to develop novel approaches to treat and even ideally prevent resistance to EGFR TKIs (tyrosine-kinase inhibitor) and other molecularly targeted therapies. This could serve as a template for other cancer types as well. Over time, this approach, broadly used, would create simultaneously, highly valuable annotated tumor specimens along with germ line DNA for high-throughput genomic studies to identify novel targets and their impact on the course of disease. Re-analyzing molecular changes in the tumor at the time of disease progression would likely be a new standard of care to guide salvage therapy.

Eligibility: Inclusion Criteria/Exclusion Criteria:
  -  Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma
  -  Presence of known sensitizing mutations in EGFR TK domain (exon 19 deletion and L858R)
  -  Absence of known resistant mutations in the EGFR TK domain (T790M)
  -  Consented to HRPO # 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma")
  -  No prior treatment for this malignancy
  -  No prior localized therapy to the biopsy site
  -  Planned treatment with standard of care afatinib at 40 mg QD (daily)
  -  Not pregnant or breastfeeding
  -  At least 18 years of age

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

Summary: This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.

Detailed description: This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.

Eligibility: Inclusion Criteria:
  -  Male and female subjects
  -  Age ≥ 18 years
  -  Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above
  Exclusion Criteria:
  -  Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer
  -  Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD

Summary: To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.


Eligibility: Inclusion Criteria:
  1. Newly diagnosed or existing COPD defined by GOLD, and FEV1 of<80% predicted and FEV1/FVC<70%
  2. Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer
  3. .Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer
  4. General anesthesia and double cavity intubation was used during operation
  5. ASA Classification of Anesthesia Risk is in category 1-3 both in baseline
  6. age from 40-80 years old
  7. Smoking cessation more than two weeks before operation
  8. SP O2>90% before surgery
  9. Hemoglobin > 10g/dl
  10. Estimated duration of surgery < 4 hours
  11. 18.5<BMI < 28
  Exclusion Criteria:
  1. Patients who had taken systemic corticosteroids in the preceding 1month before baseline
  2. Patients who had pneumonia in the preceding 1month before baseline
  3. Patients with a history of recent myocardial infarction, heart failure, tuberculosis
  4. Subject with known or suspected human immunodeficiency virus infection

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

Summary: Continuos treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.


Eligibility: Inclusion criteria:
  1. Pathologically or cytologically confirmed NSCLC
  2. Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. The staging is based on American Joint Commitee on Cancer (AJCC) Classification of Malignant Tumours (TNM) 7th edition (R12-4710)
  3. Evidence of common EGFR mutation (Del 19 and/or L858R)
  4. Age = 70 years
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01- 0787)
  6. No prior systemic therapy for metastatic or recurrent NSCLC.
  Further inclusion criteria apply.
  Exclusion criteria:
  1. Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
  2. Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
  3. Radiotherapy within 4 weeks prior to start of study treatment, except as follows:
  i.) Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  4. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
  5. Systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
  6. Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
  Further Exclusion Criteria Apply.

Relevance to patient case: not relevant