Lazertinib for Malignant Neoplasms

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hopital Nord, Marseille Cedex 20, France
Malignant Neoplasms+2 More
Lazertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Eligible Conditions

  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Malignant Neoplasms

Study Objectives

4 Primary · 21 Secondary · Reporting Duration: Up to 1 year 11 months

Day 28
Part 2: Maximum Serum Concentration (Cmax) of Amivantamab After Cycle 1 Day 1
Day 28
Part 1: Observed Serum Concentration (Ctrough) of Amivantamab on Cycle 2 Day 1
Part 2: Ease of use and Satisfaction with Amivantamab SC-CF OBDS as Assessed by Ease of use and Satisfaction Questionnaire
Day 28
Part 1: Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2
Day 28
Part 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Part 2: Observed Serum Concentration (Ctrough) of Amivantamab on Cycle 4 Day 1
Day 28
Part 2: Area Under the Concentration Time Curve from Day 1 to Day 8 (AUC[Day 1-8]) of Amivantamab of Cycle 1
Day 28
Part 1: Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4
Year 11
Part 1 and Part 2: Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring.
Part 1 and Part 2: Change from Baseline in TASQ as Assessed Over Time
Part 1 and Part 2: Duration of Response (DOR)
Part 1 and Part 2: Duration of Treatment Administration
Part 1 and Part 2: Number of Participants Infusion Related Reactions (IRRs)
Part 1 and Part 2: Number of Participants With Adverse Events (AEs)
Part 1 and Part 2: Number of Participants with AEs by Severity
Part 1 and Part 2: Number of Participants with Clinical Laboratory Abnormalities
Part 1 and Part 2: Number of Participants with Infusion Related Reactions (IRRs) by Severity
Part 1 and Part 2: Objective Response Rate (ORR)
Part 1 and Part 2: Participant Chair Time
Part 1 and Part 2: Participant Time in Treatment Room
Part 1 and Part 2: Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
Part 1 and Part 2: Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
Part 1 and Part 2: Progression-Free Survival (PFS)
Part 1 and Part 2: Rate of Successful Injections with Amivantamab SC-CF OBDS
Part 1 and Part 2: Time to Response.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Malignant Neoplasms

Trial Design

4 Treatment Groups

Part 2: Arm A2: Lazertinib with Amivantamab SC-CF
1 of 4
Part 1: Arm B1: Lazertinib with Amivantamab Intravenous (IV) Infusion
1 of 4
Part B2: Arm B2: Lazertinib with Amivantamab SC-CF OBDS
1 of 4
Part 1: Arm A1: Lazertinib with Amivantamab SC-CF
1 of 4
Experimental Treatment

640 Total Participants · 4 Treatment Groups

Primary Treatment: Lazertinib · No Placebo Group · Phase 3

Part 2: Arm A2: Lazertinib with Amivantamab SC-CFExperimental Group · 2 Interventions: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Lazertinib · Intervention Types: Drug, Drug
Part 1: Arm B1: Lazertinib with Amivantamab Intravenous (IV) InfusionExperimental Group · 2 Interventions: Lazertinib, Amivantamab Intravenous · Intervention Types: Drug, Drug
Part B2: Arm B2: Lazertinib with Amivantamab SC-CF OBDSExperimental Group · 2 Interventions: Lazertinib, Amivantamab SC-CF On-Body Delivery System (OBDS) · Intervention Types: Drug, Device
Part 1: Arm A1: Lazertinib with Amivantamab SC-CFExperimental Group · 2 Interventions: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Lazertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lazertinib
2021
Completed Phase 1
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year 11 months
Closest Location: Medical University of South Carolina · Charleston, SC
Photo of medical university of south carolina 1Photo of medical university of south carolina 2Photo of medical university of south carolina 3
1993First Recorded Clinical Trial
0 TrialsResearching Malignant Neoplasms
1235 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,228 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
705 Previous Clinical Trials
3,899,523 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have at least 1 measurable lesion, according to RECIST version 1.1.
You have an ECOG performance status of 0 to 1.
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.