Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective, External Comparator Study to Assess the Real-World Effectiveness of Lazertinib as the Second-Line Treatment Versus Platinum-based Chemotherapy in Patients With EGFR Mutation+ Locally Advanced or Metastatic NSCLC

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Lazertinib
* Drug: Platinum-based Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Target and Period: Patients aged 18 or older Target Conditions: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lazertinib<br> | Drug: Lazertinib<br>* Patients who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period<br>* Other names: YH25448;|
| Platinum-based Chemotherapy<br> | Drug: Platinum-based Chemotherapy<br>* Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period<br>* Other names: External Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative evaluation of (real-world:rw) Progression-free survival (PFS) between patients receiving Lazertinib versus Platinum-based Chemotherapy | (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. | Up to 64 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative evaluation between patients receiving Lazertinib versus Platinum-based Chemotherapy of (rw) Overall survival (OS) | (rw) OS, is defined as the time from the first administrating date of treatment(Lazertinib or Platinum-based Chemotherapy) to death. | Up to 64 months | 
| Comparative evaluation of (rw) Investigator-assessed objective response rate (ORR) between patients receiving Lazertinib versus Platinum-based Chemotherapy | (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. | Up to 64 months | 
| Comparative evaluation of (rw) Time to treatment discontinuation (TTD) between patients receiving Lazertinib versus Platinum-based Chemotherapy | (rw) TTD, is defined as the time from the first administrating date of treatment(Lazertinib or Platinum-based Chemotherapy) to treatment discontinuation. | Up to 64 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR Sensitizing Mutation, T790M mutation, EGFR TKI, Second-line, YH25448, External Comparator, Retrospective, Advanced Non-Small Cell Lung Cancer, Lazertinib