Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT05826366
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)
Study:
NCT05826366
Study Brief:
Protocol Section:
NCT05826366