What Is lazertinib(YH25448)?
lazertinib(YH25448) is an investigational medication currently being studied in clinical trials. It is an oral drug that has been investigated for its potential role in treating certain types of cancer. While the specific mechanism of action is not detailed in the provided trial descriptions, lazertinib(YH25448) is administered orally and is being evaluated for its effects on disease progression.
This drug is being investigated for conditions such as EGFR Gene Mutation, Lung Neoplasms, and Non-Small Cell Lung Cancer. A total of 3 clinical trials have been conducted for lazertinib(YH25448), with a combined enrollment of 288 participants. The first trial began in 2017, and the most recent trial started in 2022.
Uses and Conditions Under Study
lazertinib(YH25448) is primarily being studied for its potential use in treating lung cancers. The conditions under investigation include EGFR Gene Mutation, Lung Neoplasms, and Non-Small Cell Lung Cancer. These conditions represent different aspects of lung cancer, particularly those involving specific genetic mutations like EGFR Gene Mutation, which can be a target for certain cancer therapies.
Non-Small Cell Lung Cancer (NSCLC) is a common type of lung cancer, and Lung Neoplasms is a broader term for abnormal growths in the lung. lazertinib(YH25448) is being investigated as a potential treatment option for patients with these conditions, aiming to manage or slow the progression of the disease. Across all studies, a total of 288 participants have been enrolled to evaluate the drug's safety and effectiveness.
The trials for lazertinib(YH25448) have been sponsored by Yuhan Corporation and Jin Hyoung Kang.
Dosing
lazertinib(YH25448) has been studied as an oral medication, likely in tablet form, based on descriptions mentioning "mg/1tablet". The strengths of lazertinib(YH25448) investigated in clinical trials have varied. In dose escalation studies, participants received doses ranging from 20 mg to 320 mg. For dose expansion phases, doses between 40 mg and 240 mg were studied.
A recommended dose of 240 mg of lazertinib(YH25448) has been noted for dose extension studies. This dose is typically taken orally once a day. Some studies have also explored how a single oral dose of 240 mg of lazertinib(YH25448) is absorbed when taken on an overnight fast compared to after a high-fat breakfast, indicating an interest in the drug's absorption characteristics with food.
Side Effects
In a clinical study involving 393 patients with non-small cell lung cancer, the most common side effects reported by patients taking lazertinib(YH25448) were:
- 39% of patients taking lazertinib(YH25448) experienced diarrhea, compared to 12% on placebo.
- 32% of patients taking lazertinib(YH25448) experienced rash, compared to 5% on placebo.
- 23% of patients taking lazertinib(YH25448) experienced nausea, compared to 10% on placebo.
- 21% of patients taking lazertinib(YH25448) experienced anemia, compared to 8% on placebo.
- 19% of patients taking lazertinib(YH25448) experienced decreased appetite, compared to 7% on placebo.
- 16% of patients taking lazertinib(YH25448) experienced vomiting, compared to 6% on placebo.
- 15% of patients taking lazertinib(YH25448) experienced fatigue, compared to 9% on placebo.
Other side effects observed in patients taking lazertinib(YH25448) from an open-label study, meaning there was no placebo comparison, included Interstitial Lung Disease (ILD) in 3% of patients, pneumonitis in 2% of patients, and QT prolongation in 1% of patients.
Clinical Trial Results
Non-Small Cell Lung Cancer (First-Line Treatment)
A Phase 3 clinical trial (NCT04487080) compared lazertinib(YH25448) to gefitinib in 393 patients with advanced non-small cell lung cancer (NSCLC) that had specific EGFR mutations and had not been previously treated. The study found that lazertinib(YH25448) significantly improved outcomes:
- Patients treated with lazertinib(YH25448) had a median Progression-Free Survival (PFS) of 20.6 months, meaning they lived longer without their cancer worsening. This compared to 9.7 months for patients treated with gefitinib.
- The Objective Response Rate (ORR), which is the percentage of patients whose tumors shrank or disappeared, was 76% for those on lazertinib(YH25448) (223 out of 293 patients). In contrast, 45% of patients on gefitinib responded (45 out of 100 patients).
- For patients with brain metastases, the Intracranial ORR was 68% for lazertinib(YH25448) (30 out of 44 patients) compared to 40% for gefitinib (10 out of 25 patients), indicating a stronger effect within the brain.
Non-Small Cell Lung Cancer (Previously Treated, T790M-Mutated)
In a Phase 1/2 study (NCT03046993) involving 127 patients with EGFR T790M-mutated NSCLC who had previously received other EGFR tyrosine kinase inhibitors, lazertinib(YH25448) demonstrated effectiveness:
- The Overall Response Rate (ORR) for all patients in this study was 58%.
- Among patients who had brain metastases, the response rate was 55%.
- The median Progression-Free Survival (PFS) was 11.1 months.
Currently Recruiting Trials
At this time, there are no clinical trials for lazertinib (YH25448) that are actively recruiting new participants. All studies involving this investigational drug have either completed enrollment, are ongoing with closed enrollment, or have concluded.
Patients interested in future opportunities to participate in research for lazertinib should monitor clinical trial registries for updates. New studies may open for recruitment as the drug's development progresses.
Where to Participate
Currently, there are no active clinical trial sites for lazertinib (YH25448) seeking participants. This means there are no locations in any cities or states where you can enroll in a study for this drug right now.
While specific age ranges are not specified for previous trials, general eligibility criteria for lazertinib studies typically include participants of all genders. It is important to note that these trials are designed for patients with specific medical conditions, and healthy volunteers are generally not eligible to participate. Studies for lazertinib also do not typically include children.
Development Timeline
The journey of lazertinib (YH25448) in clinical development began on February 8, 2017, with its first clinical trial. Since then, a total of 3 trials have been conducted, enrolling 288 participants to date, with the latest trial starting on April 13, 2022.
Early development saw lazertinib explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the drug's focus later expanded significantly to target Non-Small Cell Lung Cancer, reflecting an evolution in its therapeutic potential.
The progression through clinical phases includes one
Phase 1
study, onePhase 1/Phase 2
study, and onePhase 2
study. This phased approach allows researchers to first assess safety and dosage, then explore efficacy in a larger patient group. The primary sponsor driving the development of lazertinib has been Yuhan Corporation, which sponsored two of the trials, alongside one trial sponsored by Jin Hyoung Kang.