NCT04854590

Completed

IMFINZI Study in Patients With Extensive Stage Small Cell Lu...

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

D419QC00006

Study Type

observational

Actual enrollment (reported)

248

Locations

1 country

Sites

18

Timeline

Study Start

April 22, 2021

Actual (reported)

Primary Completion

July 25, 2023

Actual (reported)

Study Completion

July 25, 2023

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 248 participants
Study completion date: July 25, 2023
Actual (reported)
Listed locations: 1 countries · 18 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 19, 2021
Actual (reported)
First Posted
April 22, 2021
Actual (reported)
Study Start
April 22, 2021
Actual (reported)
Primary Completion
July 25, 2023
Actual (reported)
Study Completion
July 25, 2023
Actual (reported)

Last Updated: July 24, 2024
Status Verified: July 2024
Last Update Submitted: July 23, 2024

Conditions

Carcinoma, Small Cell

Outcome Measures

Primary Outcomes (1)

Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)
16weeks

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with extensive stage small cell lung cancer

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (18)

Research Site

Chiba, Japan

Research Site

Fukuoka, Japan

Research Site

Gunma, Japan

Research Site

Hokkaido, Japan

Research Site

Hyōgo, Japan

Research Site

Kanagawa, Japan

Research Site

Miyagi, Japan

Research Site

MeSH Terms

Conditions

Carcinoma, Small Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

Toshimitsu Tokimoto
Astrazeneca KK
STUDY DIRECTOR

Enrollment

248 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 16 Weeks
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 22, 2021

Study Start

April 22, 2021

Actual (reported)

NCT00826644

Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

Phase 3Completed

NCT00537511

A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide

Phase 1/2Terminated

NCT00126828

Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer

Phase 1/2Completed

NCT00191750

A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned

Phase 2Completed

NCT02881125

Paclitaxel and Nortriptyline Hydrochloride in Treating Patients With Relapsed Small Cell Carcinoma

Phase 1Completed

NCT01900951

Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

Phase 2Unknown

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

Contact the study team to confirm eligibility.

Nagano, Japan

Research Site

Nagasaki, Japan

Research Site

Nara, Japan

Research Site

Numakunai, Japan

Research Site

Okayama, Japan

Research Site

Osaka, Japan

Research Site

Saitama, Japan

Research Site

Shizuoka, Japan

Research Site

Tokyo, Japan

Research Site

Tottori, Japan

Research Site

Wakayama, Japan

Primary Completion

July 25, 2023

Actual (reported)

Study Completion

July 25, 2023

Actual (reported)

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing: Will share
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.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04854590
Data provider: ClinicalTrials.gov
Source updated: 2024-07-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:00 UTC

Locations

JP(18)

IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations