Tarlatamab vs. Real-world Physicians’ Choice Therapies in Patients with Relapsed or Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment: Patient-level Indirect Treatment Comparison (ITC) of DeLLphi-301 vs. Flatiron Real-world Data

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Indirect treatment comparison

Study drug and medical condition

• Name of medicine, other:
  Tarlatamab
• Medical condition to be studied:
  Small cell lung cancer recurrent
• Additional medical condition(s):
  Relapsed or refractory small cell lung cancer

Population studied

• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Relapsed or refractory small cell lung cancer

Study design details

• Study design:
  A patient-level ITC study will be conducted to estimate relative treatment effects of tarlatamab vs. comparator therapies among patients with relapsed or refractory SCLC who have progressed or recurred following one platinum-based regimen and at least one other line of therapy (LOT).
• Main study objective:
  The main study objective is to estimate the relative effect of tarlatamab versus comparator therapies on overall survival (OS).
• Setting:
  All patients randomized to the 10mg cohort in parts 1 and 2 of DeLLphi-301 trial are included in this study.; Patients meeting the key selection criteria of DeLLphi-301 were identified from the Flatiron data and included in the external control cohort of this study. ;
• Comparators:
  Real-world physicians’ choice of therapy in 3L+ ES-SCLC setting
• Outcomes:
  Primary outcome: ; • OS; ; Secondary outcome: ; • Time to treatment discontinuation (TTD) ; • Time to next treatment or death (TTND)
• Data analysis plan:
  For the primary and secondary objectives, OS, TTD, and TTNTD will be compared between tarlatamab and comparator therapy groups before and after weighting, using unweighted and weighted Kaplan-Meier analyses and log rank tests. Hazard ratios will be estimated before and after weighting using unweighted and weighted Cox proportional hazards models, respectively. 95% confidence intervals (CIs) for hazard ratios will be estimated based on a robust sandwich estimator.