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Tyrosine Kinase Inhibitor

Lazertinib for Non-Small Cell Lung Cancer

Q: Are there any other similar investigations like this one?

<p>Janssen Research &#x26; Development, LLC sponsored the first Lazertinib trial in 2016. This initial study completed Phase 1 drug approval and enrolled 780 patients across 37 countries. In the 6 years since, there have been 9 additional trials with recruitment spanning 128 cities.</p>

Phase 1 & 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 33.7 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33.7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 33.7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33.7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part D: Accumulation Ratio (Rac) for Multiple Dose of Lazertinib

Part D: Apparent Plasma Clearance (CL/F) for Single Dose of Lazertinib

Part D: Apparent Plasma Clearance at Steady State (CLss/F) for Multiple Dose of Lazertinib

+19 more

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DoR)

Objective Response Rate (ORR)

+17 more

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT04075396

47%

Anaemia

47%

Diarrhoea

27%

Dyspnoea

27%

Nausea

27%

Aspartate Aminotransferase Increased

27%

Rash

20%

Hyperkalaemia

20%

Blood Alkaline Phosphatase Increased

20%

Dizziness

20%

Neutrophil Count Decreased

20%

Asthenia

20%

Alanine Aminotransferase Increased

20%

Hyponatraemia

20%

Oedema Peripheral

20%

Pain in Extremity

20%

Back Pain

20%

Paronychia

13%

Pain

13%

Decreased Appetite

13%

Hypercholesterolaemia

13%

Neutropenia

13%

Pulmonary Embolism

13%

Abdominal Pain Upper

13%

Vomiting

13%

Blood Creatinine Increased

13%

Hypermagnesaemia

13%

Paraesthesia

13%

Cough

13%

Hypercalcaemia

13%

Muscular Weakness

13%

Arthralgia

Cancer Pain

Medical Device Pain

Bronchitis

Bone Pain

Chest Pain

Onychoclasis

Dysphagia

Deep Vein Thrombosis

Dry Mouth

Neurotoxicity

Benign Prostatic Hyperplasia

Dyspepsia

Appetite Disorder

Angina Pectoris

Vertigo Positional

Musculoskeletal Chest Pain

Adrenalectomy

Vision Blurred

Covid-19

Hordeolum

Pathological Fracture

Leukopenia

Gingival Pain

Abdominal Pain

Cerebrovascular Accident

Onychomadesis

Lymphopenia

Pneumonia

Thrombocytopenia

Constipation

Disorientation

Fatigue

White Blood Cell Count Decreased

Induration

Gait Disturbance

Polydipsia

Headache

Tremor

Folliculitis

Skin Lesion

Weight Decreased

Conjunctivitis

Blood Magnesium Decreased

Troponin I Increased

Dysarthria

Pleural Effusion

Blood Sodium Decreased

Chromaturia

Skin Hyperpigmentation

Pruritus

Blood Bilirubin Increased

Rash Maculo-Papular

Dermatitis Acneiform

Troponin Increased

Polyuria

Rash Macular

Peripheral Sensory Neuropathy

Sciatica

Dysuria

Confusional State

Epistaxis

Solar Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Lazertinib 240 mg

Lazertinib 320 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part D: Outside of KoreaExperimental Treatment1 Intervention

Participants from outside of Korea with progressive disease and on prior epidermal growth factor receptor (EGFR) Tyrosine kinase inhibitor (TKI) therapy will receive recommended phase 2 doses based on safety, tolerability, efficacy and pharmacokinetics (PK) of Lazertinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

2021

Completed Phase 2

~770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yuhan CorporationIndustry Sponsor

101 Previous Clinical Trials

25,830 Total Patients Enrolled

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,663 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,249 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other continents with active research locations for this trial?

"This trial is being conducted at Advent Health Orlando, Montefiore Medical Center, City of Hope, and 5 other locations."

Answered by AI

How many people suffering from this disease will be given the chance to try this new treatment?

"Currently, this particular trial is not accepting any more patients. The study was first posted on October 16th, 2019 and has since had its information updated as recently as November 9th, 2020. If you are seeking other trials, there are 1393 active studies for carcinoma, non-small-cell lung and 10 for Lazertinib that currently have open enrollment."

Answered by AI

What is the aim of this experiment?

"The primary objective of this trial is to assess plasma concentration of lazertinib after administration of multiple doses. The secondary objectives include duration of response, overall response rate, and disease control rate."

Answered by AI

Can patients still enroll in this clinical trial?

"The clinical trial, which was last updated on November 9th 20222 is not recruiting patients at this present time. 1403 other trials are currently looking for participants."

Answered by AI

What other scientific papers have been published on Lazertinib's effects?

"There are currently 10 different clinical trials studying the effects of Lazertinib. Of these, 3 have progressed to Phase 3 testing. The primary location for these studies is Sutton, Ontario; however, there are 1,052 total locations running trials for this medication."

Answered by AI

Are there any other similar investigations like this one?

"Janssen Research & Development, LLC sponsored the first Lazertinib trial in 2016. This initial study completed Phase 1 drug approval and enrolled 780 patients across 37 countries. In the 6 years since, there have been 9 additional trials with recruitment spanning 128 cities."

Answered by AI

Recent research and studies

Advances in TherapyJournal

Effects of Acid-reducing Agents on the Pharmacokinetics of Lazertinib in Patients with EGFR Mutation-positive Advanced Non-small-cell Lung Cancer

Kim, Bomin, Jungwook Lee, Hyunwoo Jang, Nami Lee, Jaydeep Mehta, and Seong Bok Jang. 2022. “Effects of Acid-reducing Agents on the Pharmacokinetics of Lazertinib in Patients with EGFR Mutation-positive Advanced Non-small-cell Lung Cancer”. Advances in Therapy. Springer Science and Business Media LLC. doi:10.1007/s12325-022-02286-z.

clinicaltrials.govStudy

A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

2019. "A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04075396.