<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/NCT04416633</url>
  </required_header>
  <id_info>
    <org_study_id>D133HC00003</org_study_id>
    <nct_id>NCT04416633</nct_id>
  </id_info>
  <brief_title>Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced, NSCLC</brief_title>
  <official_title>A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Durvalumab in Indian Adult Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</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>
      A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian&#xD;
      adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) and&#xD;
      urothelial cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 30, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the safety of durvalumab among locally advanced unresectable non-small cell lung carcinoma and metastatic urothelial carcinoma</measure>
    <time_frame>12 Months</time_frame>
    <description>Number, frequency and proportion of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease/pneumonitis-like events, and on-study deaths.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Unresectable Non-small Cell Lung Cancer (NSCLC) and Urothelial Cancer</condition>
  <arm_group>
    <arm_group_label>Durvalumab</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm, Durvalumab , IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>500-mg/120-mg IV</description>
    <arm_group_label>Durvalumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed, written and dated informed consent prior to any study specific&#xD;
             Procedures&#xD;
&#xD;
          2. Male or female aged 18 years or older&#xD;
&#xD;
          3. As per local prescribing information and in view of positive benefit-risk assessment,&#xD;
             patient prescribed Durvalumab treatment as per independent clinical judgment of&#xD;
             treating physician for either&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Concurrent enrolment in another clinical study, unless it is an observational&#xD;
             (non-interventional) clinical study or the follow-up period of an interventional study&#xD;
&#xD;
          2. Current or prior use of immunosuppressive medication within 14 days before the first&#xD;
             dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or&#xD;
             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of&#xD;
             prednisone, or an equivalent corticosteroid. Systemic steroid administration required&#xD;
             to manage toxicities arising from radiation therapy delivered as part of the&#xD;
             chemoradiation therapy for locally advanced NSCLC is allowed.&#xD;
&#xD;
          3. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab.&#xD;
&#xD;
          4. For NSCLC cohort only:&#xD;
&#xD;
               1. Mixed small cell and non-small cell lung cancer histology&#xD;
&#xD;
               2. Any unresolved toxicity CTCAE &gt;Grade 2 from the prior chemoradiation therapy.&#xD;
&#xD;
               3. Patients with ≥Grade 2 pneumonitis from prior chemoradiation therapy&#xD;
&#xD;
          5. Active or prior documented autoimmune disease within the past 2 years, inflammatory&#xD;
             bowel disease (eg, Crohn's disease, ulcerative colitis), primary immunodeficiency,&#xD;
             organ transplant that requires therapeutic immunosuppression, hypersensitivity to&#xD;
             study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis.&#xD;
&#xD;
             NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic&#xD;
             treatment (within the past 2 years) are not excluded.&#xD;
&#xD;
          6. Female patients who are pregnant, breast-feeding or male or female patients of&#xD;
             reproductive potential who are not employing an effective method of birth control&#xD;
&#xD;
          7. Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of the study drug or interpretation of patient safety or study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bangalore</city>
        <zip>560017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bangalore</city>
        <zip>560022</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Delhi</city>
        <zip>110085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Faridabad</city>
        <zip>121001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gurgaon</city>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kolkata</city>
        <zip>700160</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mohali</city>
        <zip>160055</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mumbai</city>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mumbai</city>
        <zip>400053</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mumbai</city>
        <zip>400056</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <zip>110005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</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>Durvalumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </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/NCT04416633
org study id: D133HC00003
nct id: NCT04416633
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian
      adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) and
      urothelial cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To assess the safety of durvalumab among locally advanced unresectable non-small cell lung carcinoma and metastatic urothelial carcinoma
time frame: 12 Months
description: Number, frequency and proportion of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease/pneumonitis-like events, and on-study deaths.
arm group label: Durvalumab
arm group type: Other
description: Single arm, Durvalumab , IV
intervention type: Drug
intervention name: Durvalumab
description: 500-mg/120-mg IV
arm group label: Durvalumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Durvalumab
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Informed Consent Form (ICF)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home