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

NCT ID: NCT05862194

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 534 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2023-03-20

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Lazertinib

Lazertinib

Intervention Type: DRUG

Patients who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period

Platinum-based Chemotherapy

Platinum-based Chemotherapy

Intervention Type: DRUG

Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period

Interventions

Lazertinib

Patients who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period

Intervention Type: DRUG

Platinum-based Chemotherapy

Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period

Intervention Type: DRUG

Other Intervention Names

YH25448; External Control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

YMC051

Identifier Type: -

Identifier Source: org_study_id