Trial Title:
Imfinzi/Imjudo NSCLC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI
NCT ID:
NCT05826366
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
To collect information of safety in patients with unresectable advanced or recurrent
non-small cell lung cancer who receive combination therapy of IMJUDO, IMFINZI and other
platinum-based anti-cancer agents under actual use in the postmarketing setting.
Detailed description:
This investigation will be conducted to collect information of safety in patients with
unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who receive
combination therapy of IMJUDO Intravenous Infusion 25mg, IMFINZI Intravenous Infusion
120mg, 500mg and other platinum-based anti-cancer agents under actual use in the
postmarketing setting.
The investigation will be conducted as one of the additional pharmacovigilance activities
in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the
Ministerial Ordinance on Good Postmarketing Study Practice (GPSP Ordinance) and for the
purpose of application for reexamination under Article 14-4 of the Act on Securing
Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Among the safety specifications defined in the Japan Risk Management Plan of IMJUDO and
IMFINZI, the following items are set as the safety specifications for this study.
Interstitial lung disease, Colitis/Severe diarrhoea/Gastrointestinal perforation, Hepatic
function disorder/Hepatitis/Cholangitis sclerosing, Endocrine disorders (Dysfunction
thyroid, Adrenal dysfunction, Pituitary dysfunction), Type 1 diabetes mellitus, Renal
disorder (interstitial nephritis, etc.), Myositis, Myocarditis, Myasthenia gravis, Immune
thrombocytopenic purpura, Encephalitis, Severe skin disorder, Nerve disorder (including
guillain-barre syndrome), Infusion reaction, Pancreatitis, Rhabdomyolysis, Meningitis,
Febrile neutropenia during combination treatment with chemotherapy, Embryo-fetal
toxicity, Use in patients with a history of organ transplant (including haematopoietic
stem cell transplant)
Criteria for eligibility:
Study pop:
Patients with unresectable advanced or recurrent NSCLC
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- All patients who receive IMJUDO, IMFINZI and other platinum-based anti-cancer agents
for their unresectable advanced or recurrent NSCLC
Exclusion Criteria:
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Akita
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Aomori
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ehime
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Fukushima
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Gifu
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Gunma
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ibaraki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ishikawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Iwate
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kagawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kagoshima
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kochi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kumamoto
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Mie
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Miyagi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Miyazaki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nagano
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nara
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Oita
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Shizuoka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tochigi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tottori
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Toyama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamagata
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamaguchi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamanashi
Country:
Japan
Start date:
June 2, 2023
Completion date:
November 16, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05826366
