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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Lazertinib; Drug: Platinum-based Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 534

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will include patients with Epidermal Growth Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Retrospective; EGFR TKI; Lazertinib; Advanced Non-Small Cell Lung Cancer; YH25448; Second-line; T790M mutation; EGFR Sensitizing Mutation; External Comparator
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Lazertinib
• Other Study ID Numbers: YMC051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes