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NCT Number: NCT05862194

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Lazertinib

Drug

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

Other names: YH25448

Platinum-based Chemotherapy

Drug

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

Other names: External Control

Primary outcomes

  1. Comparative evaluation of (real-world:rw) Progression-free survival (PFS) between patients receiving Lazertinib versus Platinum-based Chemotherapy

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
May 17, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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