Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Safety study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Tarlatamab

Anatomical Therapeutic Chemical (ATC) code

(L01FX33) tarlatamab
tarlatamab

Medical condition to be studied

Small cell lung cancer
Population studied

Short description of the study population

Study enrollment will be offered to patients meeting the eligibility criteria at participating medical sites in South Korea. Subjects prescribed tarlatamab in routine clinical practice according to the approved therapeutic indications (SCLC), dosage, and administration in South Korea will be enrolled on a continuous basis at participating sites. Enrollment will start (estimated Q3 2025) after launch of tarlatamab in South Korea and is planned to end 4 years later if enrollment targets are met. If the target enrollment can’t be reached within 4 years, a discussion with MFDS will be needed to determine if a study period extension is required. Patients will be enrolled at participating sites and will be followed for up to 60 days after completion of 4 cycles (approximately 17 weeks) of tarlatamab use, 60 days after discontinuation of tarlatamab, withdrawal of consent, death, or lost to follow-up, whichever occurs first.

Age groups

  • 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)

Special population of interest, other

73
Study design details

Study design

20230176 is an observational multicenter study in patients who are prescribed tarlatamab within the approved indication in a post-marketing setting in South Korea.

Main study objective

The main objective of this study is to describe safety of tarlatamab in post-marketing clinical practice within the approved indication.
The Secondary objective is to describe effectiveness of tarlatamab in clinical practice within the approved indication.

Setting

Inclusion Criteria:
• Subjects prescribed tarlatamab in clinical practice according to the approved
therapeutic indications, dosage, and administration in South Korea
• Subjects or their authorized representative who provide written informed consent to
participate in this study

Exclusion Criteria:
• Subjects with contraindications as listed on the approved local label
• Subjects concurrently participating in another interventional study will not be allowed
to participate in this study
• Subjects who have received any prior treatment with tarlatamab prior to Day 1 of
study

Outcomes

Primary outcomes:
- Incidence of adverse events
- Incidence of serious adverse events
- Incidence of adverse drug reactions
- Incidence of serious adverse drug reactions
- Incidence of unexpected adverse events
- Incidence of unexpected serious adverse events
- Incidence of unexpected adverse drug reactions
- Incidence of unexpected serious adverse drug reactions
- Incidence of adverse events leading to tarlatamab discontinuation
- Incidence of fatal events

Secondary outcomes:
- Overall Response Rate (ORR) at each follow-up visit and end of study (EOS)
- Clinical outcome measure by the investigator at EOS assigning one of the four descriptions: Improved, not changed, disease progression, unable to evaluate

Data analysis plan

The data will be summarized descriptively. The cumulative incidence of adverse events will be presented as frequency and percentage.