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IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

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: NCT04854590
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch

Condition or disease
Carcinoma, Small Cell

Detailed Description:
To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 16 Weeks
Official Title: IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade) [ Time Frame: 16weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Patients with extensive stage small cell lung cancer
Criteria

Inclusion Criteria:

-Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.

Exclusion Criteria:

-Patients who have no treatment history with the product (i.e.,durvalumab)

Contacts and Locations
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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): NCT04854590


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

Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Toshimitsu Tokimoto Astrazeneca KK
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04854590    
Other Study ID Numbers: D419QC00006
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
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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Small Cell Lung Carcinoma
Carcinoma, Small Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type