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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

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 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%
Blood Creatinine Increased
23%
Headache
23%
Vomiting
23%
Fatigue
23%
Decreased Appetite
23%
Back Pain
23%
Arthralgia
23%
Dyspnoea
23%
Rash
15%
Oedema Peripheral
15%
Dry Skin
15%
Alanine Aminotransferase Increased
15%
Myalgia
15%
Pain in Extremity
15%
Asthenia
15%
Anaemia
8%
Vision Blurred
8%
Lymphocyte Count Decreased
8%
Affect Lability
8%
Amylase Increased
8%
Troponin I Increased
8%
Dry Eye
8%
Abdominal Pain
8%
Aspartate Aminotransferase Increased
8%
Hypoaesthesia
8%
Neutropenia
8%
Chest Pain
8%
Gait Disturbance
8%
Platelet Count Decreased
8%
Troponin Increased
8%
Weight Decreased
8%
White Blood Cell Count Decreased
8%
Hyperkalaemia
8%
Muscle Rigidity
8%
Muscular Weakness
8%
Amnesia
8%
Epilepsy
8%
Paraesthesia
8%
Memory Impairment
8%
Neuropathy Peripheral
8%
Taste Disorder
8%
Pollakiuria
8%
Depressed Mood
8%
Insomnia
8%
Sleep Disorder
8%
Epistaxis
8%
Dysphonia
8%
Deep Vein Thrombosis
8%
Glossitis
8%
Hot Flush
8%
Malignant Neoplasm Progression
8%
Cognitive Disorder
8%
Hypoacusis
8%
Constipation
8%
Palpitations
8%
Pulmonary Embolism
8%
Upper Respiratory Tract Infection
8%
Bronchitis
8%
Covid-19
8%
Thrombocytopenia
8%
Erythema
8%
Papule
8%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lazertinib 320 mg
Lazertinib 240 mg

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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,241 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,041 Total Patients Enrolled

Media Library

Amivantamab Intravenous (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05388669 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A: Lazertinib with Amivantamab SC-CF, Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Intravenous Highlights & Side Effects. Trial Name: NCT05388669 — Phase 3
Amivantamab Intravenous (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388669 — Phase 3
~136 spots leftby Sep 2025
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