araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib

Summary: The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Detailed description: Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

Eligibility: Inclusion Criteria:
  1. Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma
  2. Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University.
  3. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database.
  4. All patients were with Karnofsky performance status over 70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions.
  Exclusion Criteria:
  1. Cardiac disease and hemorrhagic disease were excluded.
  2. Patients with lung cavitation before apatinib treated.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

Summary: Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.


Eligibility: Inclusion Criteria:
  -  Age：18~70 years;
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
  -  Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
  -  EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
  -  No indications for radiation therapy
  -  Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
  -  Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI
  Exclusion Criteria:
  -  Small Cell Lung Cancer
  -  central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
  -  Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
  -  Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
  -  have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  -  Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
  -  with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
  -  Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
  -  get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
  -  Have suffered from hemorrhagic disease or coagulation dysfunction
  -  diagnosed with disease which will severely endanger the security of patients or influence the completion of this research

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer

Detailed description: The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer .According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 39 , according to 10% censoring,the expected sample size is 43.

Eligibility: Inclusion Criteria:
  -  18，Pathologically proven Non squamous non small cell lung cancer
  -  No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
  -  Progress after second line
  -  PS score 0-2
  Exclusion Criteria:
  -  Patients received second line treatment
  -  Patients received treatment of Anlotinib or Docetaxel
  -  Patients with contraindication of chemotherapy
  -  Pregnant or breast feeding women

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer

Summary: This study was designed to explore the efficacy and safety of Crizotinib as a first-line treatment for advanced NSCLC with ROS1 rearrangement positive mutation in the real world, explore the new drug resistance mechanism of ROS1 under Crizotinib treatment and the consistency of plasma and tissue detection driving genes, and finally evaluate the mutation spectrum of plasma dynamic detection driving genes. In predicting the risk of disease progression.

Detailed description: This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced non-squamous non-small cell lung cancer (NSCLC) using Crizotinib ROS1 rearrangement positive mutation was conducted to observe the efficacy and safety of Crizotinib regimen in the real world.Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between NGS and plasma gene test (NGS) at the progression of clozotinib treatment; 3. Drug resistance mechanism of clozotinib in ROS1 rearrangement positive NSCLC; 4. Plasma drug resistance. Large panel dynamic driven gene mutation analysis was used to construct disease progression risk model.

Eligibility: Inclusion Criteria:
  -  ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
  -  ROS1 Arranged Positive
  -  ROS1 Arranged Detection Method is NGS
  -  First Diagnosis and Treatment
  -  Treatment Plan is Kazolinib 250mg po bid
  Exclusion Criteria:
  -  Patients received antitumor treatment before
  -  Patients with contraindication of chemotherapy
  -  Pregnant or breast feeding women

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer

Summary: The purpose of this study is to assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer

Detailed description: This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.

Eligibility: Inclusion Criteria:
  -  18，Pathologically proven non small cell lung cancer
  -  Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
  -  Squamous cell carcinoma，no gene detection
  -  Progress after second line
  -  PS score >2
  Exclusion Criteria:
  -  Patients received apatinib or Vinorelbine treatment before
  -  EGFR, ALK or ROS1 mutation
  -  Patients with contraindication of chemotherapy
  -  Pregnant or breast feeding women

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC

Summary: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS.
  In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
  -  Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC;
  -  Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and ROS1;
  -  Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening;
  -  No prior systemic treatment;
  -  Adequate hematologic and end organ function;
  -  Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 6 months after the last dose Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception from screening through 6 months after the last dose.
  Exclusion Criteria:
  -  Significant cardiovascular disease;
  -  Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies;
  -  History of autoimmune disease;
  -  Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome;
  -  Severe infection within 4 weeks prior to randomization;
  -  Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study;
  -  Major surgical procedure within 4 weeks prior to randomization;
  -  History of hemoptysis within 12 weeks prior to randomization;
  -  Inadequately controlled hypertension;
  -  Evidence of bleeding diathesis or coagulopathy;
  -  Prior allogeneic bone marrow transplantation or solid organ transplant;
  -  Positive test for HIV, and patients with active hepatitis B or hepatitis C.

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Summary: This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.

Detailed description: This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data.

Eligibility: Inclusion Criteria:
  1. Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
  2. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  4. Adequate organ function as defined by the following criteria
  Exclusion Criteria:
  1. Use of any anticancer drug subsequent to crizotinib prior to study entry
  2. Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
  3. Use of drugs that are known potent CYP3A4 inducers
  4. Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Summary: The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Detailed description: Primary objective:
  Progression-free survival
  Secondary objecive:
  Overall survival, best objective response, disease control rate and adverse events
  Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.
  Plan of the Study:
  1. This is a retrospective study.
  2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
  3. Duration of Treatment: Treatment was administered until disease progressed.

Eligibility: Inclusion Criteria:
  -  Age between 20-85 years old
  -  Histologically proven metastatic colorectal cancer (mCRC).
  -  Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
  -  Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.
  Exclusion Criteria:
  -  Patients who do not meet the including criteria or unwilling to participate

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Descriptive Observational Study ALK-2016-CPHG

Summary: Descriptive Observational Study.
  Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Detailed description: Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.

Eligibility: Inclusion criteria
  -  Age ≥ 18 years
  -  Locally advanced or metastatic NSCLC
  -  Patient ALK gene rearrangement or ROS1 gene rearrangement
  -  Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
  -  Patient followed up by a physician in a hospital pulmonary medicine department
  -  Subject of reproductive age, using an effective method of contraception
  -  Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.
  Non-inclusion criteria
  -  Patient included within the scope of an interventional therapeutic trial
  -  Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
  -  Patient not available for follow-up throughout the duration of the study
  -  Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy

Summary: Doctors are recruiting patients receiving care for lung cancer at the Wake Forest Baptist Comprehensive Cancer Center asking about needs and experiences during immunotherapy. Immunotherapy is a new treatment for lung cancer. The research is to better understand patients' perspectives on what immunotherapy is like and will provide important information to help understand the symptoms patients experience, the impact of treatment on daily life, ways that people adapt to the challenges of treatment, and services that may help people live better during treatment.

Detailed description: The overall primary objective of this pilot study is to describe patient-reported symptom burden, unmet supportive care needs, and use of and interest in supportive care services in stage IV non-small cell lung cancer patients undergoing first or second line immunotherapy and to identify psychosocial factors associated with these outcomes.
  50 stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center. The study team will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed stage IV (per AJCC 7th edition) non-small cell lung cancer.
  -  Receiving first or second line immunotherapy.
  -  ECOG Performance status of 0-3.
  -  English-speaking
  Exclusion Criteria:
  -  Unable to provide informed consent

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib

Summary: The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.


Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Advanced biopsy-proven metastatic non-small cell lung cancer
  -  Somatic activating mutation in EGFR in a tumor biopsy
  -  Prior treatment with osimertinib with response followed by disease progression
  -  No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
  -  Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy after disease progression on osimertinib prior to study initiation
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated
  -  Karnofsky performance status (KPS) >/= 70%
  -  Age >/= 18 years old
  -  Ability to swallow oral medication
  -  Adequate organ function
  -  AST, ALT </= 3 x ULN
  -  Total bilirubin </= 1.5x ULN
  -  Creatinine </= 1.5x ULN OR calculated creatinine clearance >/= 60ml/min
  -  Absolute neutrophil count (ANC) >/= 1000 cells/mm3
  -  Hemoglobin>/=8.0 g/dL
  -  Platelets >/=75,000/mm3
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Any radiotherapy within 1 week of starting treatment on protocol.
  -  Any major surgery within 1 weeks of starting treatment on protocol.
  -  Any evidence of active clinically significant interstitial lung disease
  -  Continue to have unresolved > grade 1 toxicity from any previous treatment Treatment
  -  Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
  -  Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids

Relevance to patient case: not relevant