xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05988697</url>
    </required_header>
    <id_info>
      <org_study_id>DAT 1</org_study_id>
      <nct_id>NCT05988697</nct_id>
    </id_info>
    <brief_title>Evaluate the Efficacy and Safety of Aspirin in Combination With Trametinib and Dabrafenib</brief_title>
    <official_title>An Observational Phase II Study to Evaluate the Efficacy and Safety of Aspirin in Combination With Trametinib and Dabrafenib in Advanced Non-small Cell Lung Cancer Patients With BRAF V600E Mutation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to observe the safety and efficacy of Aspirin combined with&#xD;
        Trametinib and Dalafenib in the treatment of advanced BRAF V600E mutated non-small cell lung&#xD;
        cancer (NSCLC)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        lung cancer is the leading cause of morbidity and mortality in China, and non-small cell lung&#xD;
        cancer (NSCLC) accounts for about 85% of all lung cancers. The incidence of V-Raf murine&#xD;
        sarcoma viral oncogene homolog B1 (BRAF) mutations in NSCLC is 1.5% to 3.5%, and BRAF V600&#xD;
        accounts for about 30-50% of all BRAF mutations, among them, V600E mutation is the most&#xD;
        common . NSCLC patients with BRAF V600 mutation have poor prognosis and shorter overall&#xD;
        survival (OS). In terms of drug therapy for these patients didn't get a better clinical&#xD;
        benefits of chemotherapy and immunotherapy, and the progression free survival (PFS) of&#xD;
        chemotherapy is only 1.5~4.2 months . The PFS of patients with BRAF-mutated NSCLC treated&#xD;
        with immune checkpoint inhibitors was only 3.1 to 5.3 months . In recent years, the&#xD;
        application of targeted therapy has brought new hope for patients with lung cancer BRAF&#xD;
        mutation. In three cohorts of the Phase II clinical trial BRF113928, the BRAF inhibitor&#xD;
        darafenib, was demonstrated has a significant efficacy as a single agent in treated patients&#xD;
        with BRAF V600E mutation (cohort A), combined with mitogen-activated protein kinase (MAPK)&#xD;
        kinase (MEK) inhibitor trametinib in treated patients (cohort B), and combined with&#xD;
        trametinib in treated patients (cohort C), respectively. Objective response rates (ORR) were&#xD;
        33.0%, 63.2%, and 64.0%, and PFS were 5.5, 9.7, and 14.6 months, respectively. BRF113928&#xD;
        research shows that Dabrafenib combined with Trametinib had good efficacy in the treatment of&#xD;
        BRAFV600 mutant NSCLC patients, regardless of whether it was used as first-line therapy or&#xD;
        back-line therapy, and was superior to BRAF single-agent targeted therapy. In terms of&#xD;
        safety, the most common adverse event (AE) of Dabrafenib combined with Trametinib was fever.&#xD;
        In cohort B and cohort C, the incidence of fever of all grades was 46% and 64%, respectively,&#xD;
        but most of them were grade , while the incidence of grade 3-4 AE was relatively low, 2% and&#xD;
        11%. In general, it is safe and controllable . The main management methods for fever AE&#xD;
        caused by Dabrafenib combined with Trametinib as follows: after the first occurrence of fever&#xD;
        syndrome, the patient should stop taking both drugs and immediately start oral antipyretic&#xD;
        therapy. After the fever, it is still recommended to continue the drug for 3 days before&#xD;
        stopping the fever treatment. The selection and usage of related antipyretic drugs should be&#xD;
        comprehensively evaluated by doctors, and the options include non-steroidal anti-inflammatory&#xD;
        drugs, acetaminophen, and anethene. At present, the latest NCCN and CSCO both regard&#xD;
        Dabrafenib combined with Trametinib as the preferred first-line treatment for BRAF V600E&#xD;
        mutated advanced NSCLC patients . In March 2023, Dabrafenib combined with Trametinib entered&#xD;
        the national medical insurance directory, reducing the economic burden of patients. However,&#xD;
        drug resistance to targeted drugs is inevitable. Studies have shown that the resistance&#xD;
        mechanism of BRAF/MEK inhibitors is mainly mediated by the PI3K-Akt-mtor and RAS-RAF-MEK&#xD;
        pathways, such as cell cycle related gene changes, PI3K-AKT pathway activation, NRAS/KRAS&#xD;
        mutations, etc. Drug resistance mechanism of Dabrafenib combined with Trametinib is&#xD;
        complicated, there are few opportunities to use targeted drugs, also lack of clear&#xD;
        recommendation for follow-up treatment guidelines, usually systemic treatment such as&#xD;
        immunotherapy and chemotherapy are adopted. How to overcome the resistance mechanism, delay&#xD;
        drug resistance, and further prolong the PFS and OS of patients of Dabrafenib combined with&#xD;
        Trametinib still need more exploration.&#xD;
  &#xD;
        Previous epidemiological studies have suggested that aspirin may reduce the incidence of&#xD;
        certain cancers, including lung cancer. A study from the United States included 365 patients&#xD;
        with advanced non-small cell lung cancer treated with Osimertinib, 77 of whom were taking&#xD;
        aspirin while taking Osimertinib. The results showed that the median PFS of patients treated&#xD;
        with aspirin was 21.3 months, which was significantly longer than the median PFS of 11.6&#xD;
        months of patients treated with Osimertinib alone. However, the median OS of patients treated&#xD;
        with aspirin was lower than that of patients treated with Osimertinib alone, which was 32.3&#xD;
        months. Combined with aspirin could significantly reduce the risk of death of patients by&#xD;
        44%, suggesting that EGFR-TKI combined with aspirin could improve the patients' PFS and&#xD;
        reduce the risk of death and bleeding events. And the same as the targeted drugs, Dabrafenib&#xD;
        who joint Trametinib whether can combine with aspirin? How safe is it? Can the combination of&#xD;
        aspirin with Dabrafenib and Trametinib improve the PFS and OS of patients? Aspirin has&#xD;
        antipyretic and analgesic effects, while one of the most common adverse reactions of&#xD;
        Dabrafenib combined with Trametinib is fever. Can the combination of Dabrafenib combined with&#xD;
        Trametinib reduce the occurrence of adverse events of fever? At present, in the field of lung&#xD;
        cancer, there is no literature report on aspirin combined with Dabrafenib and Trametinib in&#xD;
        the treatment of BRAF V600E mutated advanced NSCLC. In order to solve the above problem,&#xD;
        further improve the BRAF V600E mutations in NSCLC patients with long-term survival, we&#xD;
        proposed the observational phase II study to evaluate the efficacy and safety of aspirin&#xD;
        combined with Dabrafenib and Trametinib in advanced NSCLC with BRAF V600E mutation.&#xD;
  &#xD;
        Primary Objectives: To determine the progression-free survival time (PFS) of aspirin combined&#xD;
        with Dabrafenib and Trametinib;&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
        A, To determine the 3 year Overall Survival (OS) in the aspirin combined with Dabrafenib and&#xD;
        Trametinib; B, To observe the Objective Response Rate (ORR) of aspirin combined with&#xD;
        Dabrafenib and Trametinib; C, To observe the Disease Control Rate (DCR) in aspirin combined&#xD;
        with Dabrafenib and Trametinib; D, To observe the fever-reducing rate of aspirin combined&#xD;
        with Dabrafenib and DabrafenibTrametinib E, To observe the risk of coronary events in&#xD;
        patients with aspirin combined with Dabrafenib and Trametinib.&#xD;
  &#xD;
        Subjects were treated with aspirin in combination with trametinib and dalafenib. The subject&#xD;
        will be observed on the drug for 36 months, unless the subject develops tumor progression&#xD;
        (deterioration) or a toxic reaction that is difficult to tolerate.&#xD;
  &#xD;
        Treatment drug: Dabrafenib 150 mg BID, Trametinib 2 mg QD, Aspirin 100 mg/tablet, 1&#xD;
        tablet/time, QD.&#xD;
  &#xD;
        Dabrafenib or trametinib should be interrupted or adjusted in time if a participant developed&#xD;
        toxicity during treatment. In case of severe drug toxicity, the participant must discontinue&#xD;
        the drug.. If the subject develops therapeutic toxicity of Asprin during the administration,&#xD;
        the investigator shall interrupt or adjust the dose of aspirin in a timely manner. If serious&#xD;
        drug toxicity occurs, the subject must stop taking the drug.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>PFS</measure>
      <time_frame>3 years</time_frame>
      <description>Progression-free survival (PFS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients with fever</measure>
      <time_frame>C</time_frame>
      <description>Refers to the proportion of patients with fever from the beginning of treatment to the end of follow-up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>3 years</time_frame>
      <description>3 year Overall Survival (OS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ORR</measure>
      <time_frame>3 years</time_frame>
      <description>The Objective Response Rate (ORR) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib. ORR will be analyzed using tests, and logistic regression methods will be used to explore other factors that influence the outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCR</measure>
      <time_frame>3 years</time_frame>
      <description>The Disease Control Rate (DCR) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib. DCR will be analyzed using tests, and logistic regression methods will be used to explore other factors that influence the outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Risk of coronary events</measure>
      <time_frame>3 years</time_frame>
      <description>Risk of coronary events was calculated in 36 patients treated with aspirin combined with Dabrafenib and TrametinibTrametinib</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Effectiveness evaluation/efficacy analysis</measure>
      <time_frame>3 years</time_frame>
      <description>Univariate analysis of the relationship between lung cancer and treatment regimens: DFS and OS were used to compare whether there was a statistical difference (P-value less than or equal to 0.05) in the overall survival curve between the experimental and control groups by log-rank test; Multifactor analysis: PFS and OS will use a COX-proportional hazard model to estimate the hazards ratio and explore other factors that influence efficacy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Security assessment</measure>
      <time_frame>3 years</time_frame>
      <description>Security analysis data sets will be used for analysis. descriptive statistics, adverse events (AE), laboratory test results (blood biochemistry, liver and kidney function, coagulation and stool routine, etc.) and important vital signs (such as blood pressure) were mainly used to summarize and analyze the list.</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">36</enrollment>
    <condition>NSCLC</condition>
    <condition>BRAF V600E Mutation</condition>
    <condition>Advanced Cancer</condition>
    <condition>Stage IIIB NSCLC</condition>
    <condition>Stage IV NSCLC</condition>
    <arm_group>
      <arm_group_label>Observation group</arm_group_label>
      <description>Primary IIIB-IV BRAF V600E mutated advanced non-small cell lung cancer in a population of patients with advanced lung cancer proposed to be treated with Trametinib， Dabrafenib and Asprin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Combind asprin with Trametinib and Dabrafenib</intervention_name>
      <description>Treatment drug: Dabrafenib 150 mg BID, Trametinib 2 mg QD, Aspirin 100 mg/tablet, 1 tablet/time, QD</description>
      <arm_group_label>Observation group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study is aimed at patients with advanced non-small cell lung cancer with BRAF V600E&#xD;
          mutation in primary stage IIIB-IV. Dabrafenib and Trametinib are proposed for the treatment&#xD;
          of advanced lung cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Inoperable stage IIIB-IV patients with non-small cell lung cancer;&#xD;
  &#xD;
            2. BRAF V600E mutation;&#xD;
  &#xD;
            3. Dabrafenib and Trametinib are planned for treatment, and the survival period is&#xD;
               expected to be more than 3 months;&#xD;
  &#xD;
            4. ECOG PS 0/1;&#xD;
  &#xD;
            5. The diameter of the primary lesion should be at least 1cm;&#xD;
  &#xD;
            6. Previous or current aspirin treatment was allowed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The patient is currently receiving other anticoagulant therapy;&#xD;
  &#xD;
            2. The patient was previously treated with systemic anti-NSCLC;&#xD;
  &#xD;
            3. The patient had other positive driver mutations, including EGFR, ALK, ROS1, MET14,&#xD;
               RET, etc.&#xD;
  &#xD;
            4. The patient had contraindications for dalafenib or trametinib and aspirin use;&#xD;
  &#xD;
            5. Patients who refused follow-up visits;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>He Yong, MD</last_name>
      <phone>86-23-68757791</phone>
      <email>heyong@dphospital.tmmu.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
      <investigator_full_name>Yong He</investigator_full_name>
      <investigator_title>Director of Department of Respiratory Diseases</investigator_title>
    </responsible_party>
    <keyword>NSCLC</keyword>
    <keyword>Asprin</keyword>
    <keyword>Dabrafenib</keyword>
    <keyword>Trametinib</keyword>
    <keyword>PFS</keyword>
    <keyword>BRAF V600E mutation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trametinib</mesh_term>
      <mesh_term>Dabrafenib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05988697
  org study id: DAT 1
  nct id: NCT05988697
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to observe the safety and efficacy of Aspirin combined with
        Trametinib and Dalafenib in the treatment of advanced BRAF V600E mutated non-small cell lung
        cancer (NSCLC)
  lung cancer is the leading cause of morbidity and mortality in China, and non-small cell lung
        cancer (NSCLC) accounts for about 85% of all lung cancers. The incidence of V-Raf murine
        sarcoma viral oncogene homolog B1 (BRAF) mutations in NSCLC is 1.5% to 3.5%, and BRAF V600
        accounts for about 30-50% of all BRAF mutations, among them, V600E mutation is the most
        common . NSCLC patients with BRAF V600 mutation have poor prognosis and shorter overall
        survival (OS). In terms of drug therapy for these patients didn't get a better clinical
        benefits of chemotherapy and immunotherapy, and the progression free survival (PFS) of
        chemotherapy is only 1.5~4.2 months . The PFS of patients with BRAF-mutated NSCLC treated
        with immune checkpoint inhibitors was only 3.1 to 5.3 months . In recent years, the
        application of targeted therapy has brought new hope for patients with lung cancer BRAF
        mutation. In three cohorts of the Phase II clinical trial BRF113928, the BRAF inhibitor
        darafenib, was demonstrated has a significant efficacy as a single agent in treated patients
        with BRAF V600E mutation (cohort A), combined with mitogen-activated protein kinase (MAPK)
        kinase (MEK) inhibitor trametinib in treated patients (cohort B), and combined with
        trametinib in treated patients (cohort C), respectively. Objective response rates (ORR) were
        33.0%, 63.2%, and 64.0%, and PFS were 5.5, 9.7, and 14.6 months, respectively. BRF113928
        research shows that Dabrafenib combined with Trametinib had good efficacy in the treatment of
        BRAFV600 mutant NSCLC patients, regardless of whether it was used as first-line therapy or
        back-line therapy, and was superior to BRAF single-agent targeted therapy. In terms of
        safety, the most common adverse event (AE) of Dabrafenib combined with Trametinib was fever.
        In cohort B and cohort C, the incidence of fever of all grades was 46% and 64%, respectively,
        but most of them were grade , while the incidence of grade 3-4 AE was relatively low, 2% and
        11%. In general, it is safe and controllable . The main management methods for fever AE
        caused by Dabrafenib combined with Trametinib as follows: after the first occurrence of fever
        syndrome, the patient should stop taking both drugs and immediately start oral antipyretic
        therapy. After the fever, it is still recommended to continue the drug for 3 days before
        stopping the fever treatment. The selection and usage of related antipyretic drugs should be
        comprehensively evaluated by doctors, and the options include non-steroidal anti-inflammatory
        drugs, acetaminophen, and anethene. At present, the latest NCCN and CSCO both regard
        Dabrafenib combined with Trametinib as the preferred first-line treatment for BRAF V600E
        mutated advanced NSCLC patients . In March 2023, Dabrafenib combined with Trametinib entered
        the national medical insurance directory, reducing the economic burden of patients. However,
        drug resistance to targeted drugs is inevitable. Studies have shown that the resistance
        mechanism of BRAF/MEK inhibitors is mainly mediated by the PI3K-Akt-mtor and RAS-RAF-MEK
        pathways, such as cell cycle related gene changes, PI3K-AKT pathway activation, NRAS/KRAS
        mutations, etc. Drug resistance mechanism of Dabrafenib combined with Trametinib is
        complicated, there are few opportunities to use targeted drugs, also lack of clear
        recommendation for follow-up treatment guidelines, usually systemic treatment such as
        immunotherapy and chemotherapy are adopted. How to overcome the resistance mechanism, delay
        drug resistance, and further prolong the PFS and OS of patients of Dabrafenib combined with
        Trametinib still need more exploration.
  
        Previous epidemiological studies have suggested that aspirin may reduce the incidence of
        certain cancers, including lung cancer. A study from the United States included 365 patients
        with advanced non-small cell lung cancer treated with Osimertinib, 77 of whom were taking
        aspirin while taking Osimertinib. The results showed that the median PFS of patients treated
        with aspirin was 21.3 months, which was significantly longer than the median PFS of 11.6
        months of patients treated with Osimertinib alone. However, the median OS of patients treated
        with aspirin was lower than that of patients treated with Osimertinib alone, which was 32.3
        months. Combined with aspirin could significantly reduce the risk of death of patients by
        44%, suggesting that EGFR-TKI combined with aspirin could improve the patients' PFS and
        reduce the risk of death and bleeding events. And the same as the targeted drugs, Dabrafenib
        who joint Trametinib whether can combine with aspirin? How safe is it? Can the combination of
        aspirin with Dabrafenib and Trametinib improve the PFS and OS of patients? Aspirin has
        antipyretic and analgesic effects, while one of the most common adverse reactions of
        Dabrafenib combined with Trametinib is fever. Can the combination of Dabrafenib combined with
        Trametinib reduce the occurrence of adverse events of fever? At present, in the field of lung
        cancer, there is no literature report on aspirin combined with Dabrafenib and Trametinib in
        the treatment of BRAF V600E mutated advanced NSCLC. In order to solve the above problem,
        further improve the BRAF V600E mutations in NSCLC patients with long-term survival, we
        proposed the observational phase II study to evaluate the efficacy and safety of aspirin
        combined with Dabrafenib and Trametinib in advanced NSCLC with BRAF V600E mutation.
  
        Primary Objectives: To determine the progression-free survival time (PFS) of aspirin combined
        with Dabrafenib and Trametinib;
  
        Secondary Objectives:
  
        A, To determine the 3 year Overall Survival (OS) in the aspirin combined with Dabrafenib and
        Trametinib; B, To observe the Objective Response Rate (ORR) of aspirin combined with
        Dabrafenib and Trametinib; C, To observe the Disease Control Rate (DCR) in aspirin combined
        with Dabrafenib and Trametinib; D, To observe the fever-reducing rate of aspirin combined
        with Dabrafenib and DabrafenibTrametinib E, To observe the risk of coronary events in
        patients with aspirin combined with Dabrafenib and Trametinib.
  
        Subjects were treated with aspirin in combination with trametinib and dalafenib. The subject
        will be observed on the drug for 36 months, unless the subject develops tumor progression
        (deterioration) or a toxic reaction that is difficult to tolerate.
  
        Treatment drug: Dabrafenib 150 mg BID, Trametinib 2 mg QD, Aspirin 100 mg/tablet, 1
        tablet/time, QD.
  
        Dabrafenib or trametinib should be interrupted or adjusted in time if a participant developed
        toxicity during treatment. In case of severe drug toxicity, the participant must discontinue
        the drug.. If the subject develops therapeutic toxicity of Asprin during the administration,
        the investigator shall interrupt or adjust the dose of aspirin in a timely manner. If serious
        drug toxicity occurs, the subject must stop taking the drug.
  observational model: Cohort
  time perspective: Prospective
  measure: PFS
  time frame: 3 years
  description: Progression-free survival (PFS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib
  measure: Proportion of patients with fever
  time frame: C
  description: Refers to the proportion of patients with fever from the beginning of treatment to the end of follow-up.
  measure: OS
  time frame: 3 years
  description: 3 year Overall Survival (OS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib
  measure: ORR
  time frame: 3 years
  description: The Objective Response Rate (ORR) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib. ORR will be analyzed using tests, and logistic regression methods will be used to explore other factors that influence the outcome.
  measure: DCR
  time frame: 3 years
  description: The Disease Control Rate (DCR) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib. DCR will be analyzed using tests, and logistic regression methods will be used to explore other factors that influence the outcome.
  measure: Risk of coronary events
  time frame: 3 years
  description: Risk of coronary events was calculated in 36 patients treated with aspirin combined with Dabrafenib and TrametinibTrametinib
  measure: Effectiveness evaluation/efficacy analysis
  time frame: 3 years
  description: Univariate analysis of the relationship between lung cancer and treatment regimens: DFS and OS were used to compare whether there was a statistical difference (P-value less than or equal to 0.05) in the overall survival curve between the experimental and control groups by log-rank test; Multifactor analysis: PFS and OS will use a COX-proportional hazard model to estimate the hazards ratio and explore other factors that influence efficacy.
  measure: Security assessment
  time frame: 3 years
  description: Security analysis data sets will be used for analysis. descriptive statistics, adverse events (AE), laboratory test results (blood biochemistry, liver and kidney function, coagulation and stool routine, etc.) and important vital signs (such as blood pressure) were mainly used to summarize and analyze the list.
  arm group label: Observation group
  description: Primary IIIB-IV BRAF V600E mutated advanced non-small cell lung cancer in a population of patients with advanced lung cancer proposed to be treated with Trametinib， Dabrafenib and Asprin
  intervention type: Drug
  intervention name: Combind asprin with Trametinib and Dabrafenib
  description: Treatment drug: Dabrafenib 150 mg BID, Trametinib 2 mg QD, Aspirin 100 mg/tablet, 1 tablet/time, QD
  arm group label: Observation group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: He Yong, MD
  phone: 86-23-68757791
  email: heyong@dphospital.tmmu.edu.cn
  responsible party type: Principal Investigator
  investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  investigator full name: Yong He
  investigator title: Director of Department of Respiratory Diseases
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Trametinib
  mesh term: Dabrafenib
  sharing ipd: Undecided