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Monoclonal Antibodies

Lazertinib + Amivantamab for Non-Small Cell Lung Cancer (PALOMA-3 Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations confirmed by an FDA-approved or other validated test

Have progressed on or after osimertinib (or another approved 3rd generation EGFR tyrosine kinase inhibitor) and platinum-based chemotherapy

Must not have

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Participant has leptomeningeal disease or spinal cord compression not definitively treated with surgery or radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 year 11 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new, easier to use formulation of amivantamab, which has the potential to reduce administration time and improve the patient and physician experience.

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after treatment with osimertinib or similar drugs and chemotherapy. They should be relatively healthy, able to perform daily activities (ECOG 0-1), have at least one measurable tumor, and recovered from previous cancer therapy side effects.

What is being tested?

The study tests a new way to give the drug amivantamab by injecting it under the skin instead of into a vein. This could make treatment quicker and easier. Participants will receive either this new subcutaneous version combined with lazertinib or the standard intravenous amivantamab also with lazertinib.

What are the potential side effects?

Amivantamab can cause reactions where injected, rash, muscle pain, tiredness, infusion-related reactions when given intravenously, as well as potential breathing problems like shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced or has spread, and tests show specific EGFR mutations.

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My cancer progressed after treatment with osimertinib or similar drug and chemotherapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have a history of lung scarring or inflammation.

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I have untreated spinal or brain membrane cancer.

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I have brain metastases that are causing symptoms or getting worse.

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I have pain from my cancer that isn't managed well.

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I've had more than one cancer treatment after initial platinum-based chemo and EGFR inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 year 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 year 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 year 11 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2

For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1

For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1

Secondary study objectives

Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring

Change from Baseline in TASQ as Assessed Over Time

Duration of Response (DOR)

+17 more

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT04075396

62%

Nausea

54%

Diarrhoea

23%

Headache

23%

Arthralgia

23%

Vomiting

23%

Decreased Appetite

23%

Blood Creatinine Increased

23%

Fatigue

23%

Dyspnoea

23%

Back Pain

23%

Rash

15%

Alanine Aminotransferase Increased

15%

Asthenia

15%

Oedema Peripheral

15%

Myalgia

15%

Dry Skin

15%

Pain in Extremity

15%

Anaemia

Depressed Mood

Chest Pain

White Blood Cell Count Decreased

Amnesia

Vision Blurred

Lymphocyte Count Decreased

Gait Disturbance

Glossitis

Epilepsy

Affect Lability

Deep Vein Thrombosis

Hyperkalaemia

Troponin Increased

Muscle Rigidity

Dry Eye

Abdominal Pain

Hypoaesthesia

Sleep Disorder

Hot Flush

Taste Disorder

Pollakiuria

Troponin I Increased

Aspartate Aminotransferase Increased

Amylase Increased

Muscular Weakness

Epistaxis

Neutropenia

Platelet Count Decreased

Weight Decreased

Memory Impairment

Neuropathy Peripheral

Insomnia

Paraesthesia

Dysphonia

Malignant Neoplasm Progression

Cognitive Disorder

Hypoacusis

Constipation

Palpitations

Pulmonary Embolism

Upper Respiratory Tract Infection

Bronchitis

Covid-19

Thrombocytopenia

Erythema

Papule

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Lazertinib 320 mg

Lazertinib 240 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: Arm B: Lazertinib with Amivantamab Intravenous (IV) InfusionExperimental Treatment2 Interventions

Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.

Group II: Arm A: Lazertinib with Amivantamab SC-CFExperimental Treatment2 Interventions

Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

Not yet FDA approved

0 / 8Eligibility criteria met