araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

Detailed description: This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Eligibility: Inclusion Criteria:
  -  Participant (male or female) ≥18 years of age
  -  Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  -  Participants in the Dose-Expansion Component must have one of the following genotypic aberrations: RTK mutations, amplifications or rearrangements, KRASG12, BRAF Class 3, or NF1 LOF mutations
  -  Adequate hematologic, hepatic and renal function
  -  Participant able to understand and voluntarily sign the informed consent form (ICF) and able to comply with the study visit schedule and other protocol requirements.
  -  Participants willing to agree to not father a child/become pregnant and comply with effective contraception criteria
  Exclusion Criteria:
  -  Known or suspected leptomeningeal or brain metastases or spinal cord compression
  -  Primary central nervous system (CNS) tumors
  -  Clinically significant cardiac disease
  -  Active, clinically significant interstitial lung disease or pneumonitis
  -  History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
  -  Known HIV infection
  -  Active/chronic hepatitis B or C infection
  -  Any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
  -  Females who are pregnant or breastfeeding

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

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: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer

Summary: this study is to analyze the survival condition of different groups about non-small cell lung cancer patients with KRAS mutations。The groups are made according to the treatment regime,brain metastases and gene mutation


Eligibility: Inclusion Criteria:
  -  advanced non-small cell lung cancer stage IIIB/IV
  -  KRAS mutation
  -  non-squmous
  Exclusion Criteria:
  -  squmous non-small cell lung cancer

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

Summary: This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.

Detailed description: According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.

Eligibility: Inclusion Criteria:
  -  ≥18，Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer
  -  ALK rearrangement detection method is NGS and Ventana
  -  Primary treatment of first diagnosis
  -  The treatment was Crizotinib 250mg po bid Exclusion Criteria
  -  Patients received antitumor treatment before
  -  Patients with contraindication of chemotherapy
  -  Pregnant or breast feeding women

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous Non-small Cell Lung Cancer

Summary: This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.

Detailed description: A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T 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 tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.

Eligibility: Inclusion Criteria:
  -  EGFR mutation(19del/L858R)
  -  advanced non-saquamous non-small cell lung cancer
  -  primary treatment of first diagnosis
  -  performance status（0-1)
  Exclusion Criteria:
  -  other genes mutation
  -  saquamous

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

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: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Mechanisms of Immune Deficiency

Summary: 1. The purpose of this study is to learn more about the changes in genes, cells and proteins that cause immune deficiency diseases.
  2. The early stages of the study will focus on two groups of patients:
  1. members of families in which several persons have symptoms or medical histories that suggest immune deficiency.
  2. Patients who have received treatments with medications or drugs that affect functions of the immune system (secondary immune deficiencies).
  It is hoped that studies will provide guidelines for extension of the research to other patient groups. Up to 200 patients and family members will be invited to participate.

Detailed description: The experiments that are proposed in this portion of the study are intended to:
  1. characterize the significance of the variant form of EZH2 identified in this family. They will characterize the degree of methylation of lysine 27 of histone H3 in subjects with the variant and members of the same family who have the wild type gene. The functional methyltransferase activity of the variant and wild type genes will be measured.
  2. characterize the current status of B-cell maturation and function in subjects with either the variant gene and the wild type gene.
  3. characterize B-cell function (antibody production) and the quality of antibody produced after immunizations in subjects with the wild type gene or the variant gene.

Eligibility: Inclusion Criteria:
  1. Immunodeficiency disease; or
  2. family member of individual with immunodeficiency disease
  Exclusion Criteria:
  1. Persons with immune deficiencies that are secondary to other diseases such as malignancies.
  2. Persons who do not have immune deficiencies, persons who are not meet eligibility criteria

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）

Summary: Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer

Detailed description: Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Eligibility: Inclusion Criteria:
  -  1.Age at least 18 years.
  -  2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III).
  -  3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
  -  4.ECOG PS : 0 to 1.
  -  5.Estimated life expectancy of more than 12 weeks.
  Exclusion Criteria:
  -  1.Prior exposure to any anti-angiogenesis drugs.
  -  2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis.
  -  3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  -  4.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
  -  5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

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
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC

Summary: Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.

Detailed description: Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Eligibility: Inclusion Criteria:
  -  ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
  -  Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
  -  No prior systemic treatment for non-squamous NSCLC
  -  Negative in EGFR&ALK&ROS1
  -  Main organs function is normal
  Exclusion Criteria:
  -  Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
  -  Symptoms of brain metastases cannot be controlled and treated within less than 21 days
  -  Have participated in other clinical trials of anti-tumor medicine within 4 weeks
  -  Get any severe diseases or the ones that cannot be controlled

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Summary: This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.


Eligibility: Inclusion Criteria:
  1. BRAF V600 mutation in solid tumor.
  2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
  3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
  4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
  5. ECOG performance status of 0-1.
  6. Life expectancy ≥ 3 months.
  7. Ability to take the medicine orally.
  8. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hypersensitivity to study drug ingredients or their analogues.
  2. Prior therapy with MEK-inhibitor.
  3. Receiving any other anti-cancer therapy at the same time .
  4. Active central nervous system (CNS) lesion.
  5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
  6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
  7. Uncontrolled concomitant diseases or infectious diseases.
  8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
  9. History of HIV,HCV,HBV infection.
  10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
  11. Serum HCG test is positive.
  12. Other conditions that increase the risk of study and influence the result.

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Combination of Pembrolizumab With Chemoradiation for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Summary: This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.

Detailed description: Esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in China), while ESCC is the most common subtype in Asia (more than 90 % in china). Radical resection is thought to be the mainstay of esophageal cancer treatment and preoperative CRT is well applied in treating locally advanced esophageal cancer. In a multicohort, phase IB study, pembrolizumab was used in 23 unresectable esophageal cancer patients. In this clinical trial, the incidence of grade 3 treatment-related adverse events was 39 % without the appearance of grade 4 and higher-grade adverse event, while the overall response rate reached 30 %. The safety of immune checkpoint therapy for unresected esophageal cancers using nivolumab, a different PD-1 monoclonal antibody, has also been confirmed by high quality clinical trials.
  This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy using pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer.

Eligibility: Inclusion Criteria:
  -  A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
  1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  3. Patients approve and sign the informed consent
  Exclusion Criteria:
  -  1. Patients with active autoimmune disease or history of autoimmune disease 2. Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications 3. Subjects with a history of symptomatic interstitial lung disease 4. History of allergy to study drug components 5. Women must not be pregnant or breast-feeding 6. Men with female partners (WOCBP) that are not willing to use contraception 7. Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy 8. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Relevance to patient case: not relevant