September 8, 2021JTO Clinical and Research ReportsOpen Access

No clinically relevant QTcF prolongation was observed at any dose level, with a predicted QTcF increase of 2.2 msec (upper bound 90% CI: 3.6 msec) at the therapeutic dose of 240 mg/d, and no clinically relevant LVEF decrease.

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Why the study?

Cardiovascular adverse events, including QT prolongation, decreased LVEF, and heart failure, have emerged as potential adverse events with certain EGFR TKI therapies.

Does lazertinib cause QT prolongation or decreased LVEF in patients with EGFR mutation-positive advanced NSCLC?

Population

181 patients with EGFR mutation-positive locally advanced or metastatic NSCLC plus preclinical models

Comparison

Lazertinib (20-320 mg/d)

Design

First-in-human clinical study supplemented by three preclinical studies

Authors

SJSeong Bok Jang KKKyeong Bae Kim SSSujin Sim

Discussion

Member takes

Overview

Cardiac monitoring may be prudent with lazertinib; leaves open long-term CV risk in EGFR-mutant NSCLC.

Structured PICO

Does lazertinib cause QT prolongation or decreased LVEF in patients with EGFR mutation-positive advanced NSCLC?

Population

181 patients with EGFR mutation-positive locally advanced or metastatic NSCLC, supplemented by preclinical models (in vitro hERG inhibition assay, ex vivo isolated perfused rabbit heart study, and in vivo telemetry-instrumented beagle dog study)

Intervention

Lazertinib (20-320 mg/d)

Outcome

QTcF prolongation, time-matched concentration-QTcF relationship, change of LVEF, and cardiac failure-associated AEssafety

Lazertinib demonstrates a favorable cardiac safety profile with no clinically relevant QT prolongation or LVEF decrease in patients with EGFR-mutated advanced NSCLC.

Cite This Study

Jang et al. (2021) studied this question.

synapsesocial.com/papers/6a7ac9d514b028facf0e8e01 https://doi.org/10.1016/j.jtocrr.2021.100224

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September 8, 2021JTO Clinical and Research ReportsOpen Access

No clinically relevant QTcF prolongation was observed at any dose level, with a predicted QTcF increase of 2.2 msec (upper bound 90% CI: 3.6 msec) at the therapeutic dose of 240 mg/d, and no clinically relevant LVEF decrease.

View Full Paper

Ask AI

Bookmark

Why the study?

Cardiovascular adverse events, including QT prolongation, decreased LVEF, and heart failure, have emerged as potential adverse events with certain EGFR TKI therapies.

Does lazertinib cause QT prolongation or decreased LVEF in patients with EGFR mutation-positive advanced NSCLC?

Population

181 patients with EGFR mutation-positive locally advanced or metastatic NSCLC plus preclinical models

Comparison

Lazertinib (20-320 mg/d)

Design

First-in-human clinical study supplemented by three preclinical studies

Authors

SJSeong Bok Jang KKKyeong Bae Kim SSSujin Sim

Discussion

Member takes

Overview

Cardiac monitoring may be prudent with lazertinib; leaves open long-term CV risk in EGFR-mutant NSCLC.

Structured PICO

Does lazertinib cause QT prolongation or decreased LVEF in patients with EGFR mutation-positive advanced NSCLC?

Population

Intervention

Lazertinib (20-320 mg/d)

Outcome

QTcF prolongation, time-matched concentration-QTcF relationship, change of LVEF, and cardiac failure-associated AEssafety

Lazertinib demonstrates a favorable cardiac safety profile with no clinically relevant QT prolongation or LVEF decrease in patients with EGFR-mutated advanced NSCLC.

Cite This Study

Jang et al. (2021) studied this question.

synapsesocial.com/papers/6a7ac9d514b028facf0e8e01 https://doi.org/10.1016/j.jtocrr.2021.100224

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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