Amivantamab + Lazertinib for Lung Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Helena A. Yu, MD - MSK Thoracic Medical ...

Overseen byHelena Yu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The researchers think that the study drugs, amivantamab and lazertinib, may be an effective treatment for people who have metastatic NSCLC with an EGFR mutation. Both drugs work to target cancer cells with an EGFR mutation, and this targeting action could stop or slow the growth of cancer cells. The researchers are doing this study to find out how well amivantamab and lazertinib work against metastatic NSCLC with an EGFR mutation.

Research Team

Helena Yu, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My organs are functioning well.

I have new or worsening brain metastases.

I have cancer cells in my spinal fluid.

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Exclusion Criteria

I do not have any active or chronic liver diseases.

You have a positive hepatitis B surface antigen (HBsAg) test.

You have a positive test for hepatitis C.

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Treatment Details

Interventions

Amivantamab (Monoclonal Antibodies)
Lazertinib (Small Molecule Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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