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

Clinical trial: A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

Summary: The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, this combination of drugs has on people with EGFR mutant lung cancer.


Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Advanced biopsy-proven metastatic non-small cell lung cancer
  -  Either have not started an EGFR TKI or may have started osimertinib within the last 9 weeks
  -  Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA
  -  Evidence of a concurrent P53 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
  -  Evidence of a concurrent RB1 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
  -  Must have a site of disease amenable to repeat biopsy and be willing to undergo a biopsy during treatment
  -  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/mm^3
  -  Hemoglobin≥8.0 g/dL
  -  Platelets ≥100,000/mm^3
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Started an EGFR TKI other than osimertinib or started osimertinib more than 9 weeks ago
  -  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
  -  Have pure small cell histology
  -  QTc>475msec or any clinically significant (as deemed by the investigator) abnormalities in rhythm or conduction or morphology of the resting EKG.
  -  Patients are to be excluded from cisplatin treatment arm if they meet any of the following criteria:
  -  Creatinine clearance < 60 ml/min
  -  Hearing impairment requiring assistive device
  -  Neuropathy
  -  The treating provider does not feel as though the patient should receive cisplatin

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

Clinical trial: High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Summary: To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.

Detailed description: Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival

Eligibility: Inclusion Criteria:
  -  Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  -  Age 1 8-75.
  -  Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2.
  -  Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
  -  No prior radiation to the thorax that would overlap with the current treatment field.
  -  Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN.
  -  A signed informed consent must be obtained prior to therapy.
  -  Induction chemotherapy is allowed.
  -  Life expectancy more than 3 months
  Exclusion Criteria:
  -  Patients with any component of small cell lung carcinoma are excluded from this study.
  -  Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  -  Prior radiotherapy that would overlap the radiation fields.
  -  Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
  -  Known hypersensitivity to paclitaxel.
  -  Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  -  Conditions precluding medical follow-up and protocol compliance

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

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

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

Clinical trial: A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study

Summary: ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.
  This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.

Detailed description: Primary objective
  -  To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.
  Secondary objectives
  -  To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;
  -  To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;
  -  To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.

Eligibility: Inclusion Criteria:
  1. Patients ≥18 years old.
  2. Provision of informed consent prior to any study specific procedures
  3. Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
  4. Have completed lung cancer operation
  5. The tumour EGFR gene mutation status test was performed as regular medical practice
  Exclusion Criteria:
  1. No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
  2. Patients withdrew consent for ICAN study;
  3. Patients in whose medical record was objected to use the existing data for scientific research

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

Clinical trial: Effect of Chemotherapy on TMB in NSCLC

Summary: Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
  -  Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
  -  ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
  Exclusion Criteria:
  -  Patient can not comply with research program requirements or follow-up;
  -  Patient will receive immunotherapy;

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

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

Clinical trial: Effect of Chemotherapy on PD-L1 in NSCLC

Summary: PD-L1 is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect PD-L1 in advanced NSCLC patients. The present study aims to evaluate whether PD-L1 will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
  -  Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
  -  ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
  Exclusion Criteria:
  -  Patient can not comply with research program requirements or follow-up;
  -  Patient will receive immunotherapy;

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

Clinical trial: EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

Summary: A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).

Detailed description: This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.

Eligibility: Inclusion Criteria:
  -  - Age ≥ 18 years
  -  ECOG performance status 0-1
  -  Adequate haematological function, coagulation, liver function and renal function
  -  Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
  -  TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
  -  Measurable or evaluable disease (according to RECIST 1.1 criteria).
  -  Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)
  Exclusion Criteria:
  -  - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.
  Patients with any known significant ophthalmologic anomaly of the ocular surface
  -  Patients who received prior chemotherapy for metastatic disease
  -  CNS metastases
  -  Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
  -  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 Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Summary: The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions

Detailed description: Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Eligibility: Inclusion Criteria:
  -  Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases
  -  Histological or cytological confirmation of EGRF positive sensitive mutation
  -  Diagnosis of brain metastases on a Gadolinium-enhanced MRI
  Exclusion Criteria:
  -  Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
  -  Previous usage of radiation with brain
  -  CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

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

Clinical trial: NGS Combined With RNAseq on Tumor Immune Escape in NSCLC

Summary: Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq

Detailed description: Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.

Eligibility: Inclusion Criteria:
  Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy
  Exclusion Criteria:
  EGFR mutant positive Alk mutant positive

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 Phase 1 Study of Engineered Donor Grafts (OrcaGraft) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Summary: This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.


Eligibility: Key Inclusion Criteria:
  1. Age ≥ 18 and ≤ 65 years at the time of enrollment
  2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or
  3. High or very high risk myelodysplasic syndrome (MDS) including both of the following:
  4. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
  5. Matched to a related or unrelated donor or to a haploidentical donor
  6. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  7. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  8. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  9. Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 3 times ULN
  Key Exclusion Criteria:
  1. Prior allogeneic HCT
  2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
  3. Planned donor lymphocyte infusion (DLI)
  4. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  5. Karnofsky performance score < 70% (Appendix 12.7)
  6. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 (Appendix 12.8)
  7. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
  8. Seropositive for HIV-1 or -2, HTLV-1 or -2
  9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  11. History of idiopathic or secondary myelofibrosis
  12. Women who are pregnant or breastfeeding

Relevance to patient case: not relevant