<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/NCT04500704</url>
  </required_header>
  <id_info>
    <org_study_id>HS-LK-2020-001</org_study_id>
    <nct_id>NCT04500704</nct_id>
  </id_info>
  <brief_title>Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Non-EGFR Driver Gene Mutant, Locally Advanced or Metastatic NSCLC</brief_title>
  <acronym>ACROSS1</acronym>
  <official_title>Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive With Concomitant Non-EGFR Driver Gene Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Multicenter, Open-label, Randomized, Control Phase III Study (ACROSS 1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu Hansoh Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, controlled, phase III study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-line Treatment in Patients&#xD;
      With Epidermal Growth Factor Receptor (EGFR) Mutation Positive With Concomitant Non-EGFR&#xD;
      Driver Gene Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A&#xD;
      Multicenter, Open-label, Randomized, Control Phase III Study (ACROSS 1).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.</time_frame>
    <description>To assess the efficacy of Almonertinib compared with Almonertinib Plus carboplatin and pemetrexed as first line therapy to EGFRm+, locally advanced or metastatic NSCLC patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the anti-tumor activity: OS</measure>
    <time_frame>Start of study drug to Survival Endpoint through study completion, an average of 3 years.</time_frame>
    <description>Overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the anti-tumor activity: ORR</measure>
    <time_frame>From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.</time_frame>
    <description>ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the anti-tumor activity: DCR</measure>
    <time_frame>From baseline, then every 6 weeks, until disease progression or discontinuation from study. The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.</time_frame>
    <description>Disease control rate (DCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the anti-tumor activity: DoR</measure>
    <time_frame>DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.</time_frame>
    <description>Duration of response (DoR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the anti-tumor activity: DepOR</measure>
    <time_frame>From baseline, then every 6 weeks, until disease progression or discontinuation from study. DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions up to 24 months.</time_frame>
    <description>Depth of response (DepOR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the safety of Almonertinib and Almonertinib plus pemetrexed and carboplatin: Number of AEs/SAEs</measure>
    <time_frame>Continuously throughout the study until 28 days after Termination of the treatment</time_frame>
    <description>Number of adverse events (AEs)/serious adverse events (SAEs)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">166</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Almonertinib 110mg PO once daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Almonertinib 110mg PO once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Almonertinib plus carboplatin and pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Almonertinib</intervention_name>
    <description>Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.</description>
    <arm_group_label>Almonertinib 110mg PO once daily</arm_group_label>
    <other_name>Ameile</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Almonertinib plus carboplatin and pemetrexed</intervention_name>
    <description>Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.</description>
    <arm_group_label>Almonertinib plus carboplatin and pemetrexed</arm_group_label>
    <other_name>Ameile</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent prior to any study specific procedures, sampling and&#xD;
             analyses.&#xD;
&#xD;
          -  Male or female, age at least 18 years.&#xD;
&#xD;
          -  Pathologically confirmed locally advanced or metastatic NSCLC (e.g. this may occur&#xD;
             systemic recurrence after prior surgery for early stage disease or patients may be&#xD;
             newly diagnosed with stage IIIB/IV disease according to AJCC v8.0). Patients must be&#xD;
             treatment-naïve for locally advanced or metastatic NSCLC. provided all other entry&#xD;
             criteria are satisfied.&#xD;
&#xD;
          -  Prior adjuvant, neo-adjuvant therapy and concurrent radiochemotherapy is permitted&#xD;
             (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed&#xD;
             since completion of therapy.&#xD;
&#xD;
          -  The tumour harbours one of the 2 common EGFR mutations known to be associated with&#xD;
             EGFR-TKI sensitivity (Ex19del, L858R), in combination with non-EGFR driver genes&#xD;
             mutations assessed by central testing using tumour tissue sample.&#xD;
&#xD;
          -  A WHO performance status equal to 0-1 with no deterioration over the previous 2 weeks&#xD;
             and a minimum life expectancy of 12 weeks.&#xD;
&#xD;
          -  At least 1 lesion that has not previously been irradiated, that has not been chosen&#xD;
             for biopsy during the study screening period, and that can be accurately measured at&#xD;
             Baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short&#xD;
             axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI),&#xD;
             whichever is suitable for accurately repeated measurements. If only one measurable&#xD;
             lesion exists, it is acceptable to be used (as a target lesion) as long as it has not&#xD;
             been previously irradiated and baseline tumour assessment scans are done at least&#xD;
             14days afar the screening biopsy is performed.&#xD;
&#xD;
          -  Females should be using adequate contraceptive measures throughout the study; should&#xD;
             not be breastfeeding at the time of screening, during the study and until 3 months&#xD;
             after completion of the study; and must have a negative pregnancy test prior to start&#xD;
             of dosing if of childbearing potential or must have evidence of non-childbearing&#xD;
             potential by fulfilling 1 of the following criteria at Screening:&#xD;
&#xD;
               1. Postmenopausal defined as age more than 50 years and amenorrheic for at least 12&#xD;
                  months following cessation of all exogenous hormonal treatments.&#xD;
&#xD;
               2. Women under 50 years old would be considered postmenopausal if they have been&#xD;
                  amenorrheic for 12 months or more, following cessation of exogenous hormonal&#xD;
                  treatments, and with luteinizing hormone (LH) and follicle-stimulating hormone&#xD;
                  (FSH) levels in the postmenopausal range for the laboratory.&#xD;
&#xD;
               3. Documentation of irreversible surgical sterilization by hysterectomy, bilateral&#xD;
                  oophorectomy, or bilateral salpingectomy, but not by tubal ligation.&#xD;
&#xD;
          -  Male patients should be willing to use barrier contraception (i.e., condoms).&#xD;
&#xD;
          -  For inclusion in study, patient must provide a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with any of the following:&#xD;
&#xD;
               1. Prior treatment with systemic anti-cancer therapy for locally advancer or&#xD;
                  metastatic NSCLC including chemotherapy, biologic therapy, immunotherapy, or any&#xD;
                  investigational drug.&#xD;
&#xD;
               2. Prior treatment with an EGFR TKI.&#xD;
&#xD;
               3. Major surgery (excluding placement of vascular access) within 4 weeks of the&#xD;
                  first dose of study drug.&#xD;
&#xD;
               4. Radiotherapy with a limited field of radiation for palliation within 4 week of&#xD;
                  the first dose of study drug, with the exception of patients receiving radiation&#xD;
                  to &gt; 30% of the bone marrow or with a wide field of radiation within 4 weeks of&#xD;
                  the first dose of study drug.&#xD;
&#xD;
               5. Medications that are predominantly CYP3A4 strong inhibitors or inducers or&#xD;
                  sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of&#xD;
                  the first dose of study drug.&#xD;
&#xD;
          -  Any concurrent and/or other active malignancy that has required treatment within 2&#xD;
             years of first dose of study drug.&#xD;
&#xD;
          -  Any unresolved toxicities from prior therapy greater than Common Terminology Criteria&#xD;
             for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the&#xD;
             exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.&#xD;
&#xD;
          -  Spinal cord compression or brain metastases unless asymptomatic, stable, and not&#xD;
             requiring steroids for at least 2 weeks prior to start of study treatment.&#xD;
&#xD;
          -  Patients who received yellow-fever vaccine or other attenuated live vaccine during&#xD;
             pemetrexed treatment.&#xD;
&#xD;
          -  Any evidence of severe or uncontrolled systemic diseases, including uncontrolled&#xD;
             hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes&#xD;
             it undesirable for the patient to participate in the trial OR which would jeopardize&#xD;
             compliance with the protocol such as active infection. Screening for chronic&#xD;
             conditions is not required.&#xD;
&#xD;
          -  Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to&#xD;
             swallow the study drug, or previous significant bowel resection that would preclude&#xD;
             adequate absorption of Almonertinib.&#xD;
&#xD;
          -  Any of the following cardiac criteria:&#xD;
&#xD;
               1. Mean resting corrected QT interval (QTc) &gt; 470 ms obtained from 3&#xD;
                  electrocardiograms (ECGs), using the screening clinic's ECG machine and&#xD;
                  Fridericia's formula for QT interval correction (QTcF).&#xD;
&#xD;
               2. Any clinically important abnormalities in rhythm, conduction, or morphology of&#xD;
                  the resting ECG (e.g., complete left bundle branch block, third-degree heart&#xD;
                  block, second-degree heart block, PR interval &gt; 250 ms).&#xD;
&#xD;
               3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic&#xD;
                  events, such as heart failure, hypokalemia, congenital long QT syndrome, family&#xD;
                  history of long QT syndrome, or unexplained sudden death under 40 years of age in&#xD;
                  first degree relatives or any concomitant medication known to prolong the QT&#xD;
                  interval.&#xD;
&#xD;
               4. Left ventricular ejection fraction (LVEF) ≤ 40%.&#xD;
&#xD;
          -  Past medical history of interstitial lung disease, drug-induced interstitial lung&#xD;
             disease, radiation pneumonitis that required steroid treatment, or any evidence of&#xD;
             clinically active interstitial lung disease.&#xD;
&#xD;
          -  Inadequate bone marrow reserve or organ function, as demonstrated by any of the&#xD;
             following laboratory values:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) &lt;1.5×109 / L&#xD;
&#xD;
               2. Platelet count &lt;100×109 / L&#xD;
&#xD;
               3. Hemoglobin &lt;90 g/L（&lt;9 g/dL）&#xD;
&#xD;
               4. Alanine aminotransferase &gt; 2.5 × upper limit of normal (ULN) if no demonstrable&#xD;
                  liver metastases or &gt; 5 × ULN in the presence of liver metastases.&#xD;
&#xD;
               5. Aspartate aminotransferase (AST) &gt; 2.5 × ULN if no demonstrable liver metastases&#xD;
                  or &gt; 5 × ULN in the presence of liver metastases.&#xD;
&#xD;
               6. Total bilirubin (TBL) &gt; 1.5 × ULN if no liver metastases or &gt; 3 × ULN in the&#xD;
                  presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or&#xD;
                  liver metastases.&#xD;
&#xD;
               7. Creatinine &gt; 1.5 × ULN concurrent with creatinine clearance &lt; 50 mL/min (measured&#xD;
                  or calculated by the Cockcroft-Gault equation); confirmation of creatinine&#xD;
                  clearance is only required when creatinine is &gt; 1.5 × ULN.&#xD;
&#xD;
          -  Women who are breastfeeding or have a positive urine or serum pregnancy test at the&#xD;
             Screening Visit.&#xD;
&#xD;
          -  History of hypersensitivity to any active or inactive ingredient of Almonertinib, or&#xD;
             to drugs with a similar chemical structure or class to Almonertinib.&#xD;
&#xD;
          -  Patients who are allergic to pemetrexed or any other component of the preparation,&#xD;
             carboplatin or other platinum containing compounds.&#xD;
&#xD;
          -  Patients with contraindications of pemetrexed and carboplatin.&#xD;
&#xD;
          -  Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion,&#xD;
             present a specific risk to the patient's safety.&#xD;
&#xD;
          -  Judgment by the Investigator that the patient should not participate in the study if&#xD;
             the patient is unlikely to comply with study procedures, restrictions, and&#xD;
             requirements.&#xD;
&#xD;
          -  Any disease or condition that, in the opinion of the Investigator, would compromise&#xD;
             the safety of the patient or interfere with study assessments.&#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>Jie Wang</last_name>
    <phone>13910704669</phone>
    <email>jiewang_hr@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jun Zhao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Chest Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhe Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Chuanhao Tang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Ping Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Dingzhi Huang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <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>Carboplatin</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04500704
org study id: HS-LK-2020-001
nct id: NCT04500704
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, randomized, controlled, phase III study.
Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-line Treatment in Patients
      With Epidermal Growth Factor Receptor (EGFR) Mutation Positive With Concomitant Non-EGFR
      Driver Gene Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A
      Multicenter, Open-label, Randomized, Control Phase III Study (ACROSS 1).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS)
time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
description: To assess the efficacy of Almonertinib compared with Almonertinib Plus carboplatin and pemetrexed as first line therapy to EGFRm+, locally advanced or metastatic NSCLC patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
measure: Assess the anti-tumor activity: OS
time frame: Start of study drug to Survival Endpoint through study completion, an average of 3 years.
description: Overall survival (OS)
measure: Assess the anti-tumor activity: ORR
time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
description: ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months
measure: Assess the anti-tumor activity: DCR
time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.
description: Disease control rate (DCR)
measure: Assess the anti-tumor activity: DoR
time frame: DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.
description: Duration of response (DoR)
measure: Assess the anti-tumor activity: DepOR
time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions up to 24 months.
description: Depth of response (DepOR)
measure: Assess the safety of Almonertinib and Almonertinib plus pemetrexed and carboplatin: Number of AEs/SAEs
time frame: Continuously throughout the study until 28 days after Termination of the treatment
description: Number of adverse events (AEs)/serious adverse events (SAEs)
arm group label: Almonertinib 110mg PO once daily
arm group type: Active Comparator
description: Almonertinib 110mg PO once daily.
arm group label: Almonertinib plus carboplatin and pemetrexed
arm group type: Experimental
description: Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
intervention type: Drug
intervention name: Almonertinib
description: Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
arm group label: Almonertinib 110mg PO once daily
other name: Ameile
intervention type: Drug
intervention name: Almonertinib plus carboplatin and pemetrexed
description: Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
arm group label: Almonertinib plus carboplatin and pemetrexed
other name: Ameile
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jie Wang
phone: 13910704669
email: jiewang_hr@sina.com
facility: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Carboplatin
mesh term: Pemetrexed
sharing ipd: No