Clinical trial NCT05862194: Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparative evaluation of (real-world:rw) Progression-free survival (PFS) between patients receiving Lazertinib versus Platinum-based Chemotherapy
timeFrame: Up to 64 months
Secondary outcomes:
measure: Comparative evaluation between patients receiving Lazertinib versus Platinum-based Chemotherapy of (rw) Overall survival (OS)
timeFrame: Up to 64 months
measure: Comparative evaluation of (rw) Investigator-assessed objective response rate (ORR) between patients receiving Lazertinib versus Platinum-based Chemotherapy
timeFrame: Up to 64 months
measure: Comparative evaluation of (rw) Time to treatment discontinuation (TTD) between patients receiving Lazertinib versus Platinum-based Chemotherapy
timeFrame: Up to 64 months
Other outcomes:
Locations:
Study officials:
References: