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

Clinical trial: Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

Summary: International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer


Eligibility: Inclusion Criteria:
  -  Verified diagnosis of non-small cell lung cancer
  -  Verified progression of the disease after or during first-line chemotherapy based on platinum drugs
  -  Absence of mutation of EGFR and ALK genes
  -  ECOG score 0-1
  -  At least one lesion, that is measurable according to RECIST 1.1 criteria
  -  Absence of severe organ pathology
  -  Anticipated live duration more that 12 weeks after screening
  -  Brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs
  Exclusion Criteria:
  -  EGFR and/or ALK mutations
  -  Patients with severe of live-threatening acute complications of the disease
  -  Intersticial lung diseases or pneumonitis
  -  Concomitant diseases that affect safety evaluation
  -  Autoimmune diseases
  -  Endocrine diseases that could not be compensated by hormonal therapy
  -  Patient needs glucocorticoids
  -  Significant liver or renal diseases
  -  Lactate dehydrogenase exceeds upper limit of normal more that 2-fold
  -  More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment
  -  Anti-tumor treatment ending less then 28 days before screening
  -  Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs
  -  Prior therapy with docetaxel
  -  Concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma
  -  Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel
  -  Pregnancy and lactation

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

Clinical trial: Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer

Summary: this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.
  -  Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS，any positive).
  -  unavailable of radical surgery or radical radiotherapy.
  -  not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.
  -  Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.
  -  Age 18-75 years old with performance status of 0 to 3.
  -  With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.
  -  Adequate hematological, biochemical and organ functions.
  Exclusion Criteria:
  -  Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  -  Evidence of interstitial lung diseases
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  -  Other situations researchers think not appropriate to enter the group

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 Prospective Study of Constructing Immune Repertoire to Monitor the Therapeutic Effect in NSCLC Patients

Summary: This study is designed to evaluate the untreated NSCLC patients. After participants have accepted chemotherapy, radiotherapy, and immunotherapy, the investigators used the next generation sequence technology (NGS) to construct immune repertoire to detective variation of patients' immune state and to monitor patients' therapeutic effect. The investigators are aim to explore the novel clone sequence as potential therapy target.

Detailed description: Lung cancer was one of the most deadly tumors in the world. The standard of care for patients is platinum-based doublet chemotherapy concurrent with radiotherapy. As for patients with a mutant epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase(ALK), EGFR or ALK tyrosine kinase inhibitors (TKIs) are the standard first-line therapy. Now, the Food and Drug Administration approved Ipilimumab, Nivolumab, and Pembrolizumab as first-line or second-line therapy for NSCLC. However, there was no reports about therapeutic effect for NSCLC patients through detecting herself immune state, immune repertoire could explore patients' immune clonality and diversity using NGS technology.The investigators look forward to illuminate the mechanism of patients antitumor action.

Eligibility: Inclusion Criteria:
  -  Pathologically verified stage IV non-small cell lung cancer without treated.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Major organs function normally
  -  Women at pregnant ages should be under contraception
  -  Willing and able to provide informed consent
  Exclusion Criteria:
  -  Pathology is mixed type•
  -  Poor vasculature
  -  Coagulopathy, or ongoing thrombolytics and/or anticoagulation
  -  Blood-borne infectious disease, e.g. hepatitis B
  -  History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
  -  Other conditions requiring exclusion deemed by physician

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

Clinical trial: A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

Summary: In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenecity.

Detailed description: This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
  Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.

Eligibility: Inclusion Criteria:
  -  Aged ≥ 18 years
  -  ECOG performance status of 0-1
  -  Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
  -  At least one measurable lesion according to RECIST v1.1.
  -  Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters
  Exclusion Criteria:
  -  Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
  -  Sensitizing EGFR mutations or ALK rearrangements
  -  Increased risk of bleeding determined by investigator based on radiographic / clinical findings
  -  History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

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 to Evaluate Effectiveness of Sublobar Dissection in Patients With Non-small Cell Lung Cancer

Summary: A study to evaluate effectiveness of sublobar dissection in patients with non-small cell lung cancer

Detailed description: This is a multi-centre real-world non-interventional observational study. The study data on patient demographic/tumor biological characteristics and clinical treatments were retrospectively collected to evaluate effectiveness of sublobar dissection in the Chinese patients with non-small cell lung cancer who received sublobar dissection.

Eligibility: Inclusion Criteria:
  -  Patients >= 18 years old;
  -  Patients who received sublobar dissection from 2014 to 2017 (segment dissection/wedge dissection/segment and wedge dissections);
  -  Patients who received selective or systematic lymphadenectomy;
  -  Pathologically diagnosed patients with non-small cell lung cancer;
  -  Pathological staging: I, II
  Exclusion Criteria:
  -  Patients who received cancer treatments before surgeries (adjuvant therapies including chemotherapies, radiotherapies, target therapies);
  -  Patients who received late-phase or intolerant palliative lobectomy or compromise sublobar dissection;

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

Clinical trial: Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC

Summary: Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.

Detailed description: Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
  -  Electronics Coordinating Grop（ECOG）score：0-2
  -  Expected survival over 3months
  -  Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）<2.5 ULN；Cr≤1.25ULN
  Exclusion Criteria:
  -  Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
  -  Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
  -  Hemorrhoid dysfunction (inernational standard ratio(INR)> 1.5 or prothrombin time (PT)> ULN + 4 seconds or activated partial thromboplastin(APTT)> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  -  Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
  -  Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
  -  Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;

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 to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer

Summary: A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

Detailed description: A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.

Eligibility: Inclusion Criteria:
  -  Patients with surgeries from 2014 to 2017;
  -  Pathologically diagnosed patients with non-small cell lung cancer;
  -  Age > 18 years old;
  -  Patients with chest surgeries before hospitalization;
  -  Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);
  Exclusion Criteria:
  - Patients with radiotherapies, chemotherapies and biological therapies for tumors

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

Clinical trial: Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

Summary: This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in combination with standard platinum-based chemotherapy in subjects with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Subjects with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., subjects with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.) Subjects with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.


Eligibility: Inclusion Criteria:
  1. Male or female, aged 18-75 years on the day of signing informed consent.
  2. Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
  Note: Subjects with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
  3. Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
  4. Subjects must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
  Exclusion Criteria:
  1. Subjects with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for subjects with non- squamous NSCLC). Subjects with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
  2. Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
  3. Prior therapies targeting PD-1, PD-L1 or PD-L2

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 to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer

Summary: The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer

Detailed description: The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

Eligibility: Inclusion Criteria:
  -  Patients with radical resection of lung cancer enrolled from 2014 to 2019;
  -  Pathologically diagnosed patients with non-small cell lung cancer;
  -  Patients with age > 18 years old;
  -  Patients who did not receive chest surgeries before hospitalization;
  -  Patients with N2 lymph nodes (+) after surgeries;
  -  Patients who received lymphadenectomy for one group or more groups of lymph nodes;
  Exclusion Criteria:
  -  Patients with second primary tumors or multiple primary tumors;

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

Clinical trial: G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

Summary: This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.
  The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and dose-finding portion (Part 1), and randomized portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients will be enrolled in the study.


Eligibility: Inclusion Criteria:
  -  Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity
  -  For Part 2, EGFR T790M mutation-positive tumor status
  -  Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range
  -  For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1
  -  For Part 2, measurable disease as defined by RECIST, Version 1.1
  -  ECOG performance status 0 to 1
  -  Adequate organ function
  Exclusion Criteria:
  -  Prior treatment with EGFR TKI within 9 days of first study dose
  -  For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC
  -  For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI
  -  For Part 2, prior chemotherapy for advanced NSCLC
  -  Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  -  Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose
  -  Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
  -  Prior hematopoietic stem cell or bone marrow transplantation

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

Clinical trial: Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

Summary: This pilot research trial studies the collection of blood samples in monitoring tumor specific mutations in patients with non-small cell lung cancer that has spread to other places in the body or cannot be removed by surgery. Collecting blood samples may help measure the changes in lung cancer, better learn methods to track cancer in the bloodstream, and improve cancer treatments.

Detailed description: PRIMARY OBJECTIVES:
  I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.
  II. Compare the sensitivity of digital droplet polymerase chain reaction (ddPCR) to that of NGS for detecting the appearance of EGFR T790M mutations in patients treated with an EGFR tyrosine kinase inhibitor.
  OUTLINE:
  Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

Eligibility: Inclusion Criteria:
  -  A diagnosis of non-small cell lung carcinoma for which the molecular profile of the primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed tissue that remains available
  -  Zubrod performance status 0 or 1
  -  Patients must have metastatic or unresectable disease and be starting a new line of systemic treatment at the time of enrollment; there are no constraints regarding the time interval between the initial collection of samples for molecular profiling studies at the time of diagnosis prior to treatment and subsequent collections of circulating cell-free deoxyribonucleic acid (DNA) or circulating tumor cells
  -  Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  -  Ability to understand and the willingness to sign a written informed consent; Note: There will be no discrimination between type of treatment or whether they are on continuous versus intermittent therapy
  Exclusion Criteria:
  -  Known severe anemia (hemoglobin [Hb] < 8g/dL)
  -  Patients will be excluded if trackable driver mutations are not identified in the primary tumor tissue

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

Clinical trial: A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment

Summary: JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study


Eligibility: Inclusion Criteria:
  Only the patients meeting all the following criteria can be eligible to participate in the trial:
  -  Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
  -  Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
  -  No exon 20 T790M mutation after failure of EGFR-TKI therapy;
  -  At least one measurable lesion (in accordance with RECIST 1.1);
  Exclusion Criteria:
  Patients who fulfill any of the following criteria must be excluded from the study:
  -  Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%;
  -  Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
  -  Previous systemic chemotherapy for advanced NSCLC;
  -  EGFR-TKI therapy within two weeks prior to enrollment;

Relevance to patient case: possibly relevant