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Monoclonal Antibodies

Amivantamab for Non-Small Cell Lung Cancer (PALOMA-2 Trial)

Phase 2

Recruiting

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

Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy

The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year 6 months

Awards & highlights

PALOMA-2 Trial Summary

This trial will study the effectiveness of a new cancer treatment, given as a shot under the skin, in combination with another existing cancer treatment. The safety of the new treatment will also be studied.

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that can't be cured by surgery or chemoradiation. Participants must have an ECOG status of 0 or 1, specific EGFR mutations, and adequate organ function. They should not have symptomatic brain metastases, a history of certain lung diseases, hypersensitivity to the drugs used in the study, significant cardiovascular disease, or uncontrolled hypertension.Check my eligibility

What is being tested?

The trial is testing amivantamab's effectiveness and safety when given as a subcutaneous co-formulation with rHuPH20 in combination treatments for various NSCLC cohorts. It also aims to characterize the safety profile of amivantamab alone in one cohort. The interventions include anticoagulants like LMWH and DOACs along with other medications such as Lazertinib and Carboplatin.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to medication components, issues related to blood clotting from anticoagulants like bleeding or bruising easily; organ inflammation; fatigue; digestive problems; changes in blood counts leading to increased infection risk; and possible heart-related complications.

PALOMA-2 Trial Eligibility Criteria

Inclusion Criteria

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

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I have taken Osimertinib for my advanced cancer, either as my first treatment or after trying another EGFR inhibitor.

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I received amivantamab and lazertinib as my first treatment for advanced cancer.

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I have been on a specific amivantamab IV treatment for at least 8 weeks without any dose reduction.

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My cancer has an EGFR mutation confirmed by a certified test.

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My last treatment was with amivantamab and lazertinib, but my cancer progressed.

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I have not had any treatment for my advanced lung cancer.

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

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My cancer has specific EGFR mutations.

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My lung cancer cannot be cured with surgery or chemoradiation.

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I have not had any treatment for my advanced lung cancer.

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My cancer progressed after my last treatment with osimertinib.

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I have a report showing my cancer has an EGFR mutation.

PALOMA-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 6 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

All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)

Cohort 4: Number of Participants with AEs by Severity

Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values

+2 more

Secondary outcome measures

All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)

All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)

All Cohorts Except Cohort 4: Number of Participants with AEs

+14 more

PALOMA-2 Trial Design

8Treatment groups

Experimental Treatment

Group I: Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+AnticoagulantExperimental Treatment4 Interventions

Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation treated will receive will receive amivantamab SC-CF injection, 1600 milligrams (mg) and 2240 mg if body weight is greater than or equal to (>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily from Cycle 1 Day 1. Participants will additionally take prophylactic anticoagulation with a direct oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH) for the first four months of study treatment (from Day 1 through Day 120) with the combination of amivantamab and lazertinib.

Group II: Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+ChemotherapyExperimental Treatment3 Interventions

Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after the combination of amivantamab and lazertinib will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression.

Group III: Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + LazertinibExperimental Treatment2 Interventions

Participants with treatment-naïve locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation will receive amivantamab SC-CF induction with 1,600 mg (or 2,240 mg if BW >=80 kg) on Cycle 1 Days 1, 8, 15, and 22, starting with Cycle 2 on Day 1 of each next 28-day cycle, amivantamab SC-CF (160 mg/mL co-formulated with rHuPH20) by manual injection at 3,520 mg (or 4,640 mg if BW >=80 kg); along with lazertinib 240 mg by mouth once daily from Cycle 1 Day 1.

Group IV: Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)Experimental Treatment1 Intervention

Participants who were previously on amivantamab IV once every 2 weeks (Q2W) regimen as part of standard of care, for at least 8 weeks, either as monotherapy or combination with lazertinib, will receive amivantamab SC-CF injection 1600 mg and 2240 mg if body weight is greater than or equal to 80 kg.

Group V: Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+ChemotherapyExperimental Treatment3 Interventions

Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression.

Group VI: Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+ChemotherapyExperimental Treatment4 Interventions

Group VII: Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + ChemotherapyExperimental Treatment3 Interventions

Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR exon20ins mutation will receive Amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle, starting with Cycle 2 along with pemetrexed 500 milligrams per meter square (mg/m^2) as intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and IV infusion carboplatin area under the concentration-time curve 5 milligrams per milliliters (mg/mL) per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles.

Group VIII: Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + LazertinibExperimental Treatment2 Interventions

Participants with treatment-naive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 19 deletion (exon19del) or exon 21 leucine 858 to arginine substitution (exon 21 L858R) mutation, will receive amivantamab SC-CF injection, 1600 milligrams (mg) or 2240 mg if body weight is greater than or equal to (>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

2014

Completed Phase 3

~5250

Direct Oral Anticoagulant (DOAC)

2015

N/A

~1040

Lazertinib

2021

Completed Phase 2

~770

Carboplatin

2014

Completed Phase 3

~6670

Low Molecular Weight Heparin (LMWH)

2017

Completed Phase 3

~12410

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,939 Total Patients Enrolled

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

745 Previous Clinical Trials

3,959,536 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05498428 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy, Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib, Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib, Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy, Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy, Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W), Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant, Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy

Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT05498428 — Phase 2

Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498428 — Phase 2

Frequently Asked Questions

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

Are there any severe side effects associated with Amivantamab?

"Amivantamab is a medication that, while still in clinical trials, has shown some efficacy in treatment. However, because this drug is still in Phase 2 of testing, there is not yet enough data to support its widespread use."

Answered by AI

Can patients still join the clinical trial?

"The clinicaltrials.gov website indicates that this study is not presently recruiting patients for participation. This trial was first announced on December 2nd, 2022 and updated November 9th, 2022. Although this specific study has completed recruitment, there are 1,394 other trials with open enrollment at the moment."

Answered by AI

Are there numerous hospitals trialing this medication within the state borders?

"The trial is based in The Huntsman Cancer Institute but also has satellite locations in Salt Lake City, Utah, University of California, Irvine and Orange, California, Swedish Cancer Institute as well as 14 other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

2022. "A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05498428.