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

Yuhan

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Lazertinib; Drug: Platinum-based Chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT05862194

YMC051

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

534 participants in 2 patient groups

Lazertinib

Treatment:

Drug: Lazertinib

Platinum-based Chemotherapy

Treatment:

Drug: Platinum-based Chemotherapy