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

Lung Cancer Clinical Trial

— Imfinzi PMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068168
• Other study ID #: D4194R00004
• Status: Recruiting
• Start date: January 30, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Chungcheongnam-do
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Gangwon
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Gyeongsangbuk-do
Korea, Republic of	Research Site	Gyeongsangnam-do
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeju
Korea, Republic of	Research Site	Jeollabuk-do
Korea, Republic of	Research Site	Jeollanam-do
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)	safety outcome	for up to 1 year after the first dose of Imfinzi
Primary	Dose interruptions	Safety outcome	for up to 1 year after the first dose of Imfinzi
Primary	Duration of treatment	Safety outcome	for up to 1 year after the first dose of Imfinzi
Secondary	Progression free survival (PFS)	efficacy outcome	for up to 1 year after the first dose of Imfinzi
Secondary	Objective response rate (ORR)	efficacy outcome	for up to 1 year after the first dose of Imfinzi
Secondary	Duration of response (DoR)	efficacy outcome	for up to 1 year after the first dose of Imfinzi