Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT05826366
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imfinzi/Imjudo NSCLC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Specific Use-results Study of IMJUDO Intravenous Infusion 25mg / IMFINZI Intravenous Infusion 120mg,500mg All Patient Investigation in Patients With Unresectable Advanced or Recurrent Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: