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

NCT05862194 | Completed FDA Drug

• 1 other identifier: YMC051
• Study Type: observational
• Target: 534
• Locations: 0 countries
• Sites: N/A

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

Keywords

EGFR Sensitizing Mutation; T790M mutation; EGFR TKI; Second-line; YH25448; External Comparator; Retrospective; Advanced Non-Small Cell Lung Cancer; Lazertinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparative evaluation between patients receiving Lazertinib versus Platinum-based Chemotherapy of (rw) Overall survival (OS)

  Up to 64 months

• Comparative evaluation of (rw) Investigator-assessed objective response rate (ORR) between patients receiving Lazertinib versus Platinum-based Chemotherapy

  Up to 64 months

• Comparative evaluation of (rw) Time to treatment discontinuation (TTD) between patients receiving Lazertinib versus Platinum-based Chemotherapy

  Up to 64 months

Study Arms (2)

Lazertinib

Drug: Lazertinib

Platinum-based Chemotherapy

Drug: Platinum-based Chemotherapy

Interventions

Lazertinib DRUG

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

Also known as: YH25448

Lazertinib

Platinum-based Chemotherapy DRUG

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

Also known as: External Control

Platinum-based Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Target and Period: Patients aged 18 or older
• Target Conditions:
• 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
• 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

You may not qualify if:

• Patients with carcinoma besides NSCLC requiring treatment
• Any unstable brain metastasis with symptomatic and/or requiring emergency treatment

Sponsors & Collaborators

• Yuhan Corporation: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lazertinib; Platinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: June 1, 2015
• Primary Completion: April 30, 2022
• Study Completion: March 20, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08