Lazertinib for Non-Small Cell Lung Cancer

Hosp. Gral. Univ. Gregorio Maranon, Madrid, Spain
Non-Small Cell Lung CancerLazertinib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing the combination of two drugs, lazertinib and amivantamab, to treat EGFR-mutated non-small cell lung cancer. The first part of the trial is to see if the recommended doses of both drugs are tolerable when used together. The second part is to see if the combination of the two drugs is effective at treating the cancer.

Treatment Effectiveness

Phase-Based Effectiveness

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Phase 1

Study Objectives

12 Primary · 15 Secondary · Reporting Duration: Up to 2.5 years

Day 21
Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1)
Day 21
Percentage of Participants with DLT (Phase 1b combination Lazertinib, Amivantamab, Platinum-doublet chemotherapy [LACP])
Day 28
Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b)
Up to 2 years
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion)
Overall Response Rate (ORR) (Phase 1b expansion)
Up to 2.5 years
CBR (Phase 1b expansion Cohorts E and F)
Clinical Benefit Rate (CBR) (Phase 1b expansion)
Clinical Benefit Rate (CBR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)
DOR (Phase 1b Expansion Cohorts E and F)
Duration of Response (DOR) (Phase 1b expansion)
Duration of Response (DOR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)
Intracranial Progression free survival (PFS) (Phase 1b Expansion E and F)
Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP)
Number of Participants with Adverse Events (AEs) (Phase 1b Expansion Cohort F)
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1 and Phase 1b)
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion Cohorts A-E)
Number of Participants with Venous Thromboembolic (VTE) Events by Severity
ORR (Phase 1b expansion Cohorts E and F)
ORR Among Participants with MET3+ Staining on Greater Than or Equal to (>=)25 Percent (%) of Tumor Cells (Phase 1b Expansion Cohorts E and F)
Overall Response Rate (ORR) (Phase 1b Expansion Cohorts A-D)
Overall Response Rate (ORR) per RECIST version 1.1 (v1.1) with NGS Analysis of Circulating Tumor ctDNA, IHC Analysis of EGFR and MET Expression (Phase 1b Expansion Cohort D)
Overall Survival (OS) (Phase 1b Expansion)
Progression free survival (PFS) (Phase 1b Expansion)
Time to Treatment Failure (TTF) (Phase 1b Expansion)
Year 5
Number of Participants with Anti-drug Antibodies Against Amivantamab (Phase 1b)
Serum Concentration of Amivantamab (Phase 1b)
Year 5
Plasma Concentration of Lazertinib (Phase 1 and Phase 1b)

Trial Safety

Phase-Based Safety

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

9 Treatment Groups

Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab
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Phase 1b (expansion) Cohort F: Amivantamab Monotherapy
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Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab
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Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab
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Phase 1 (monotherapy dose escalation): Lazertinib
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Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab
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Phase 1b (combination): Lazertinib and Amivantamab
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Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab
1 of 9
Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherap...
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Experimental Treatment

460 Total Participants · 9 Treatment Groups

Primary Treatment: Lazertinib · No Placebo Group · Phase 1

Phase 1b (expansion) Cohort D: Lazertinib and AmivantamabExperimental Group · 2 Interventions: Amivantamab, Lazertinib · Intervention Types: Drug, Drug
Phase 1b (expansion) Cohort F: Amivantamab Monotherapy
Drug
Experimental Group · 1 Intervention: Amivantamab · Intervention Types: Drug
Phase 1b (expansion) Cohort E: Lazertinib and AmivantamabExperimental Group · 2 Interventions: Amivantamab, Lazertinib · Intervention Types: Drug, Drug
Phase 1b (expansion) Cohort A: Lazertinib and AmivantamabExperimental Group · 2 Interventions: Amivantamab, Lazertinib · Intervention Types: Drug, Drug
Phase 1 (monotherapy dose escalation): Lazertinib
Drug
Experimental Group · 1 Intervention: Lazertinib · Intervention Types: Drug
Phase 1b (expansion) Cohort C: Lazertinib and AmivantamabExperimental Group · 2 Interventions: Amivantamab, Lazertinib · Intervention Types: Drug, Drug
Phase 1b (combination): Lazertinib and AmivantamabExperimental Group · 2 Interventions: Amivantamab, Lazertinib · Intervention Types: Drug, Drug
Phase 1b (expansion) Cohort B: Lazertinib and AmivantamabExperimental Group · 2 Interventions: Amivantamab, Lazertinib · Intervention Types: Drug, Drug
Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)Experimental Group · 4 Interventions: Pemetrexed, Amivantamab, Lazertinib, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Lazertinib
Not yet FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
942 Previous Clinical Trials
6,370,085 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
724 Previous Clinical Trials
3,952,243 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced or metastatic NSCLC with a rare genetic mutation that can be treated with study medication. You may have received prior treatment with specific drugs, but not more than two lines of treatment.
You have a measurable illness that can be evaluated by medical professionals.

Frequently Asked Questions

What potential harms are associated with Lazertinib use?

"Limited data exists to support the safety and efficacy of Lazertinib, leading our team at Power to rate its potential side-effects as a 1 on a 3 point scale." - Anonymous Online Contributor

Unverified Answer

Are there any prior records of Lazertinib being tested in the laboratory setting?

"Lazertinib was first investigated in 2002 at Bristol Royal Hospital for Children, with 1046 completed clinical trials since then. Currently there are 770 active studies taking place worldwide, the most prevalent being around San Francisco, California." - Anonymous Online Contributor

Unverified Answer

What maladies is Lazertinib most efficacious in addressing?

"Lazertinib is commonly prescribed for the initial treatment of various cancers, comprising advanced thymoma, carcinoma neuroendocrine and testicular cancer." - Anonymous Online Contributor

Unverified Answer

What is the cut-off for participation in this trial?

"Janssen Research & Development, LLC will be overseeing this trial from the UCSF Helen Diller Comprehensive in San Francisco and USC - Norris Comprehensive Cancer Center in Los Angeles. To achieve statistical significance within its parameters, a total of 460 compliant individuals must be recruited." - Anonymous Online Contributor

Unverified Answer

How many institutions are conducting this investigation?

"As of now, 19 clinical sites are accepting patients for this trial. This includes the UCSF Helen Diller Comprehensive in San Francisco, USC - Norris Comprehensive Cancer Center in Los Angeles, and Providence Portland Medical Center in Portland. Additional enrolment locations can be found elsewhere on the list provided." - Anonymous Online Contributor

Unverified Answer

Are any vacancies currently available for this clinical trial?

"The research study, which was originally published on September 4th 2019, is currently recruiting participants as per the details found on clinicaltrials.gov. The information was last updated in November 9th 2022." - Anonymous Online Contributor

Unverified Answer

What is the primary aim of this research project?

"This clinical trial aims to measure the safety and tolerance of participants over two years, with particular emphasis on adverse events. Secondary endpoints include plasma concentration of Lazertinib, progression-free survival rate, as well as further assessment into AEs caused by the pharmaceutical/biological agent under study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.