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Open Label, Multicenter, Real World Practice of Durvalumab in Lung Cancer (Imfinzi PMS) (Imfinzi PMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068168
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients with non-small cell lung cancer (NSCLC) or SCLC treated with Imfinzi under the approved indication in Korea.

Condition or disease
Lung Cancer

Detailed Description:

Primary objective : To assess safety of Imfinzi for patients with NSCLC or SCLC treated with Imfinzi under the approved indication in Korea

Outcome Measure:

  • Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
  • Dose interruptions
  • Duration of treatment
  • Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients with NSCLC or SCLC treated with Imfinzi under the approved indication in Korea

Outcome Measure:

  • Progression free survival (PFS)
  • Objective response rate (ORR)
  • Duration of response (DoR)

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Open Label, Multicenter, Real World Practice of Durvalumab in Lung Cancer (Imfinzi PMS)
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE) [ Time Frame: for up to 1 year after the first dose of Imfinzi ]
    safety outcome

  2. Dose interruptions [ Time Frame: for up to 1 year after the first dose of Imfinzi ]
    Safety outcome

  3. Duration of treatment [ Time Frame: for up to 1 year after the first dose of Imfinzi ]
    Safety outcome


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: for up to 1 year after the first dose of Imfinzi ]
    efficacy outcome

  2. Objective response rate (ORR) [ Time Frame: for up to 1 year after the first dose of Imfinzi ]
    efficacy outcome

  3. Duration of response (DoR) [ Time Frame: for up to 1 year after the first dose of Imfinzi ]
    efficacy outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Imfinzi treatment according to the approved label
Criteria

Inclusion Criteria:

  • Eligible for Imfinzi treatment according to the approved label; patients with NSCLC or SCLC
  • Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

  • History of hypersensitivity to excipients of Imfinzi or to drugs with a similar chemical structure or class to Imfinzi
  • Prior exposure to any anti-PD-1 or anti-PD-L1 inhibitors, including Imfinzi
  • Pregnancy and/or breast feeding
  • Current participation in any interventional trial
  • Other off-label indications according to the approved label

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068168


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Korea, Republic of
Research Site Recruiting
Hwasun-gun, Korea, Republic of, 58128
Research Site Not yet recruiting
Seoul, Korea, Republic of, 133-792
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04068168    
Other Study ID Numbers: D4194R00004
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

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.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases