Natural History, Treatment Patterns, and Real-World Clinical Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Europe and China

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

The rationale of this study is two-fold: to improve our understanding of the natural
history of ES-SCLC and to characterize variation in the ES-SCLC patient populations
across geographies.
This is a non-interventional, multi-center, multi-national, longitudinal, retrospective
cohort study of patients diagnosed with ES-SCLC. This study will use real-world
secondary care data from two distinct sources, standardized for analysis and
interpretation in tandem. European data will be abstracted from across approximately 11
sites in Europe, identified via a site-based approach from the IQVIA OEN. Data from
China will be obtained via a national level cancer registry in China, NATDSS, that
includes up to 31 provinces in China.
The population for the study will be divided into the following cohorts:
1. Diagnosed cohort, i.e., patients diagnosed with ES-SCLC, including patients
diagnosed with de novo ES-SCLC and those who have progressed from LS-SCLC.
2. 1L-treated cohort, i.e., patients diagnosed with ES-SCLC who initiated 1L treatment.
3. 2L-treated cohort, i.e., patients diagnosed with ES-SCLC who initiated 2L treatment.
4. 3L-treated cohort, i.e., patients diagnosed with ES-SCLC who initiated 3L treatment.
5. Trial-eligible cohort, i.e., patients diagnosed with ES-SCLC who either progressed
on or relapsed after 1L platinum-based chemotherapy or progressed on or relapsed
after 2L tarlatamab and who fulfill key eligibility criteria of the Phase 3 223674 trial
that can be assessed in real-world settings.

Study objectives:
6.2.1. Primary objective
1. Describe real-world overall survival (rwOS) in the diagnosed cohort.
6.2.2. Secondary objectives
2. Describe the real-world outcomes in the 1L-treated, 2L-treated, 3L-treated,
and trial-eligible cohort
3. Describe baseline demographic and clinical characteristics of patients with ES-SCLC
in all 5 cohorts.
4. Describe real-world treatment patterns in the diagnosed, 1L-treated, 2L-treated, and
trial-eligible cohorts.
6.2.3. Exploratory objectives
5. Describe the relationship between rwOS and rwORR, rwPFS and rwOS, rwPFS and
rwORR, rwPFS and rwDCR, and rwOS and rwDCR in the 1L-treated, 2L-treated,
and trial-eligible cohort.
6. Describe, where sample size allows (n≥25), real-world clinical outcomes, baseline
characteristics, and treatment patterns (objectives 1, 2 [limited to rwOS and rwORR],
3, and 4) by clinically relevant subgroups, as appropriate, in the diagnosed, 1Ltreated,
2L-treated, and trial-eligible cohorts:
7. Describe real-world clinical outcomes, baseline characteristics, and treatment
patterns (objectives 1, 2, 3, and 4) stratified by European country in the diagnosed,
1L-treated, 2L-treated, and 3L-treated cohorts.
8. Describe baseline characteristics, treatment patterns, and clinical outcomes
(objective 1, 2 [limited to rwOS and rwORR], 3, and 4) stratified by index year in the
trial-eligible cohort.
9. Describe the size of the trial-eligible cohort that emulates GSK’s Phase 3 223674
target population and assess the availability and completeness of variables to
describe clinical characteristics, treatment patterns, and outcomes.