Non-small Cell Lung Cancer
Conditions
Keywords
EGFR Sensitizing Mutation, T790M mutation, EGFR TKI, Second-line, YH25448, External Comparator, Retrospective, Advanced Non-Small Cell Lung Cancer, Lazertinib
Brief summary
This retrospective, external comparator study for Lazertinib aims to assess the real-world effectiveness of Lazertinib as the second-line treatment versus platinum-based chemotherapy in patients with epidermal growth receptor sensitizing mutation-positive, locally advanced or metastatic Non-small Lung cancer.
Interventions
DRUGLazertinib
Patients who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period
Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period
Sponsors
Yuhan Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Target and Period: Patients aged 18 or older * Target Conditions: 1. Lazertinib: * Patients diagnosed with locally progressive or metastatic non-small cell lung cancer, who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period * Patients with T790M mutation positive * Patients with an ECOG PS score of 0 to 1 at the time of initial drug administration 2. Platinum-based Chemotherapy * Patients who were diagnosed with locally advanced or metastatic non-small cell lung cancer, and previously received first or second-generation EGFR-TKI treatment during the baseline period * Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period * Patients who were confirmed positive for active EGFR mutations (L858R, Exon19Del, G719X, L861Q) during the baseline period * Patients with an ECOG PS score of 0 to 1 at the time of initial drug administration
Exclusion criteria
* Patients with carcinoma besides NSCLC requiring treatment * Any unstable brain metastasis with symptomatic and/or requiring emergency treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative evaluation of (real-world:rw) Progression-free survival (PFS) between patients receiving Lazertinib versus Platinum-based Chemotherapy | Up to 64 months | (rw) PFS, is defined as the time from the first administrating date of treatment (Lazertinib or Platinum-based Chemotherapy) to clinician-assessed progression disease or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative evaluation between patients receiving Lazertinib versus Platinum-based Chemotherapy of (rw) Overall survival (OS) | Up to 64 months | (rw) OS, is defined as the time from the first administrating date of treatment(Lazertinib or Platinum-based Chemotherapy) to death. |
| Comparative evaluation of (rw) Investigator-assessed objective response rate (ORR) between patients receiving Lazertinib versus Platinum-based Chemotherapy | Up to 64 months | (rw) ORR, is defined as the proportion of patients with the response of Complete Response (CR) or Partial Response (PR) during the follow-up period. |
| Comparative evaluation of (rw) Time to treatment discontinuation (TTD) between patients receiving Lazertinib versus Platinum-based Chemotherapy | Up to 64 months | (rw) TTD, is defined as the time from the first administrating date of treatment(Lazertinib or Platinum-based Chemotherapy) to treatment discontinuation. |
Outcome results
None listed