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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

Must not have

Other clinically active or chronic liver disease

Progressive neurological symptoms requiring escalating doses of steroids or not controlled with steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active or chronic liver diseases.

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My neurological symptoms are worsening despite increasing steroid doses.

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I have not had any radiotherapy in the week before starting this treatment.

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I have not had major surgery within the last week.

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I have severe side effects from past cancer treatments.

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I haven't had chemotherapy in the last 2 weeks.

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I haven't taken EGFR inhibitors or similar oral treatments in the last 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CNS overall response rate (ORR) (Cohort 1)

measure CNS overall response rate (ORR) (Cohort 2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

2021

Completed Phase 2

~770

0 / 17Eligibility criteria met