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Monoclonal Antibodies

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

Q: How large is the pool of applicants for this experiment?

<p>Janssen Research &#x26; Development, LLC is sponsoring a clinical trial that 640 patients are needed to participate in. NYU Langone Health Laura and Isaac Perlmutter <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, New York as well as National Jewish Health in Denver, <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a> are two of the many sites where this study will take place.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year 11 months

Awards & highlights

PALOMA-3 Trial 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.Check my eligibility

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.See study design

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.

PALOMA-3 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

PALOMA-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 11 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

47%

Anaemia

47%

Diarrhoea

27%

Dyspnoea

27%

Nausea

27%

Aspartate Aminotransferase Increased

27%

Rash

20%

Hyperkalaemia

20%

Blood Alkaline Phosphatase Increased

20%

Dizziness

20%

Neutrophil Count Decreased

20%

Asthenia

20%

Alanine Aminotransferase Increased

20%

Hyponatraemia

20%

Oedema Peripheral

20%

Pain in Extremity

20%

Back Pain

20%

Paronychia

13%

Pain

13%

Decreased Appetite

13%

Hypercholesterolaemia

13%

Neutropenia

13%

Pulmonary Embolism

13%

Abdominal Pain Upper

13%

Vomiting

13%

Blood Creatinine Increased

13%

Hypermagnesaemia

13%

Paraesthesia

13%

Cough

13%

Hypercalcaemia

13%

Muscular Weakness

13%

Arthralgia

Cancer Pain

Medical Device Pain

Bronchitis

Bone Pain

Chest Pain

Onychoclasis

Dysphagia

Deep Vein Thrombosis

Dry Mouth

Neurotoxicity

Benign Prostatic Hyperplasia

Dyspepsia

Appetite Disorder

Angina Pectoris

Vertigo Positional

Musculoskeletal Chest Pain

Adrenalectomy

Vision Blurred

Covid-19

Hordeolum

Pathological Fracture

Leukopenia

Gingival Pain

Abdominal Pain

Cerebrovascular Accident

Onychomadesis

Lymphopenia

Pneumonia

Thrombocytopenia

Constipation

Disorientation

Fatigue

White Blood Cell Count Decreased

Induration

Gait Disturbance

Polydipsia

Headache

Tremor

Folliculitis

Skin Lesion

Weight Decreased

Conjunctivitis

Blood Magnesium Decreased

Troponin I Increased

Dysarthria

Pleural Effusion

Blood Sodium Decreased

Chromaturia

Skin Hyperpigmentation

Pruritus

Blood Bilirubin Increased

Rash Maculo-Papular

Dermatitis Acneiform

Troponin Increased

Polyuria

Rash Macular

Peripheral Sensory Neuropathy

Sciatica

Dysuria

Confusional State

Epistaxis

Solar Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Lazertinib 240 mg

Lazertinib 320 mg

PALOMA-3 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.

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

Lazertinib 240 mg will be administered orally once daily. Participants will receive Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 milligrams (mg)/ 2240 mg depending on the body weight by manual injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

Not yet FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,890 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,487 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

Frequently Asked Questions

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

Could you please tell us the severity of side effects linked to Lazertinib?

"Lazertinib's safety is well-documented, as this drug has undergone Phase 3 clinical trials. This means that there is both strong evidence of its efficacy and extensive data supporting its safety profile."

Answered by AI

Are we currently enrolling people in this research project?

"Yes, according to the most recent update on clinicaltrials.gov, this research is still actively looking for participants. The trial was first posted on 8/5/2022 and was edited on 10/12/2022. A total of 640 patients are needed for the study, which is taking place at 17 different hospitals or clinics."

Answered by AI

How large is the pool of applicants for this experiment?

"Janssen Research & Development, LLC is sponsoring a clinical trial that 640 patients are needed to participate in. NYU Langone Health Laura and Isaac Perlmutter Cancer Center in New york, New York as well as National Jewish Health in Denver, Colorado are two of the many sites where this study will take place."

Answered by AI

Could you please clarify how many medical facilities are involved with this clinical trial?

"17 different hospitals or clinics are participating in this study. You can look for the site nearest you on the list of locations, which includes New york, Denver and La Jolla among other cities."

Answered by AI

What is the primary goal of this clinical trial?

"The primary objective of this study, as measured over a 28 day period, is to observe the Area Under the Concentration Time Curve (AUC) from Day 1 to Day 15 of Amivantamab. Additionally, this clinical trial will also be evaluating observed serum concentration (Ctrough) levels and the Objective Response Rate (ORR)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

2022. "A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388669.

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