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

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Platinum-based Chemotherapy; Drug: Lazertinib

• Registration Number: NCT05862194
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2022-04-30
• Study Completion: 2023-03-20
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Platinum-based Chemotherapy	Platinum-based Chemotherapy	-
Lazertinib	Lazertinib	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.