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Monoclonal Antibodies

Amivantamab + Lazertinib for Lung Cancer

Phase 2
Waitlist Available
Led By Helena Yu, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Cohort A, subjects must have new or progressing CNS metastases. Extracranial measurable disease is not required
For Cohort B, subjects must have evidence of LM involvement by positive CSF cytology or presence of CTCs in CSF. Extracranial measurable disease is not required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing two drugs, amivantamab and lazertinib, to see if they are effective against metastatic NSCLC with an EGFR mutation. Both drugs work by targeting cancer cells with an EGFR mutation.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread, and have specific EGFR mutations. They must have tried certain treatments like osimertinib without success. Participants need to be able to take oral meds, not be pregnant or breastfeeding, use effective birth control, and have good organ function. People with HIV, recent surgeries or radiotherapy, unresolved lung conditions like ILD, uncontrolled illnesses or other cancers aren't eligible.Check my eligibility
What is being tested?
The study tests amivantamab and lazertinib in treating metastatic NSCLC with an EGFR mutation. These drugs target cancer cells directly to slow down their growth. The goal is to see how well these drugs work together against this type of lung cancer after standard treatments fail.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site for amivantamab and typical drug-related issues such as fatigue, nausea, skin rash or itching due to lazertinib's action on the body's systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have new or worsening brain metastases.
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I have cancer cells in my spinal fluid.
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I have a brain tumor that is at least 5 mm big.
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My cancer with EGFR exon 20 mutation has worsened after platinum chemotherapy.
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I am 18 years old or older.
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My condition worsened despite receiving standard treatments.
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My lung cancer has spread or come back.
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My cancer has a specific genetic change known as an EGFR mutation.
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My cancer has an EGFR mutation and has worsened despite taking osimertinib.
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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CNS overall response rate (ORR) (Cohort 1)
measure CNS overall response rate (ORR) (Cohort 2)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with parenchymal brain metastasesExperimental Treatment2 Interventions
All patients in both cohorts will receive both oral lazertinib and amivantamab by intravenous injection (IV). Lazertinib dosing will start at 240 mg daily. For patients who weigh <80 kg, on C1D1 amivantamab 350 mg will be given IV via peripheral line for C1D1, D2 and D8, with 700 mg IV given on C1D2. For all other treatments, amivantamab 1050 mg IV will be given. For patients who weigh ≥ 80 kg, on C1D1 350mg IV amivantamab will be given and 1050 mg IV on C1D2, with 1400 mg IV given for all.
Group II: Patients with leptomeningeal (LM) disease with or without parenchymal brain metastasesExperimental Treatment2 Interventions
All patients in both cohorts will receive both oral lazertinib and amivantamab by intravenous injection (IV). Lazertinib dosing will start at 240 mg daily. For patients who weigh <80 kg, on C1D1 amivantamab 350 mg will be given IV via peripheral line for C1D1, D2 and D8, with 700 mg IV given on C1D2. For all other treatments, amivantamab 1050 mg IV will be given. For patients who weigh ≥ 80 kg, on C1D1 350mg IV amivantamab will be given and 1050 mg IV on C1D2, with 1400 mg IV given for all.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lazertinib
2021
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,579 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,475 Total Patients Enrolled
Helena Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
1,068 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Patients with leptomeningeal (LM) disease with or without parenchymal brain metastases, Patients with parenchymal brain metastases

Frequently Asked Questions

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

What is the aggregate number of participants involved in this trial?

"That is accurate. Clinicaltrials.gov confirms that the medical trial was initially posted on September 30th 2021 and has been actively recruiting since then. 40 participants are required from 7 different sites."

Answered by AI

Has this trial pioneered a new methodology?

"Currently, there are 13 Lazertinib trials that span 37 countries and 135 cities. The beginning of this research journey can be traced back to 2016 when Janssen Research & Development, LLC conducted a Phase 1 study which involved 780 participants. Since then, 6 further medical experiments have been concluded."

Answered by AI

Are recruiting efforts still underway for the research trial?

"Clinicaltrials.gov confirms that this clinical trial is actively recruiting new participants, having first been posted on September 30th 2021 and last amended on August 1st 2022."

Answered by AI

Are there any Canadian facilities actively participating in this research?

"Currently, 7 sites are enrolling for this trial; these locations include Montvale, Harrison and Uniondale. To reduce travel times, it is beneficial to choose the medical centre closest to you when signing up for participation."

Answered by AI

For which medical conditions is Lazertinib most commonly utilized?

"Lazertinib is a therapeutic option for those who have previously received platinum based therapy, present with exons, or suffer from malignant neoplasms."

Answered by AI

To what extent does Lazertinib guarantee a secure treatment for patients?

"Lazertinib's safety is rated a 2, as it has undergone Phase 2 trials which indicate its security but lack of data regarding efficacy."

Answered by AI

Can you provide insight into other research concerning Lazertinib?

"In 2016, Lazertinib was initially examined at Asan Medical Center. There are now 6 finished clinical trials and a further 13 active ones; many of which have been launched by Montvale in New york."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)
2021. "A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965090.
~13 spots leftby Jul 2025
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