General Use-results Survey of IMDELLTRA in Patients with Small Cell Lung Cancer Progressed after Cancer Chemotherapy (20230313)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  IMDELLTRA (active substance: tarlatamab);
• Medical condition to be studied:
  Interstitial lung disease

Population studied

• Short description of the study population:
  Small Cell Lung Cancer patients treated with tarlatamab in the post-marketing clinical setting in Japan.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Study design:
  This is a prospective observational cohort study of Small Cell Lung Cancer (SCLC) patients treated with tarlatamab in the post-marketing clinical setting in Japan.
• Main study objective:
  The main objectives of this study are to describe the incidence, frequent time of onset and management after occurrence of Interstitial Lung Disease (ILD) in Small Cell Lung Cancer (SCLC) patients treated with tarlatamab.
• Setting:
  This study will be conducted in the post-marketing clinical setting in Japan.
• Outcomes:
  The primary outcomes of this study are: ; 1. To describe the incidence of ILD.; 2. To summarize the frequent time of onset for ILD.; 3. To summarize management after occurrence of ILD.; ; The secondary outcomes of this study are: ; 1. To describe the incidence of adverse drug reactions (ADR).; 2. To describe the incidence of serious ADRs.; 3. To describe the incidence of adverse events (AE).; 4. To describe the incidence of serious AEs.
• Data analysis plan:
  As primary analysis for safety, safety specifications (ie, Interstitial Lung DiseaseILD) related will be summarized such as incidence proportion, frequent time of onset or management after onset.; ; As secondary analysis for safety, the participant incidence proportion of all AEs/ADRs will be summarized.