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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862194
• Other study ID #: YMC051
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: March 20, 2023

Study information

• Verified date: August 2023
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: March 20, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Lazertinib
Patients who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period
• Platinum-based Chemotherapy
Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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