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Premedication to Reduce Amivantamab Associated Infusion Related Reactions | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

NCT05663866•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)
•Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
•A female participant using oral contraceptives must use an additional barrier contraceptive method
•A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab
•Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
•Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib
•Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory \[or equivalent\])

Exclusion Criteria

•Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
•Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment
•Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met
•Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade less than or equal to \[\<=\] 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement therapy)
•Prior treatment with amivantamab or lazertinib

Locations (36)

Compassionate Cancer Care

Fountain Valley, California, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

UW Medicine Valley Medical Center

Renton, Washington, United States

CHU de Brest - Hopital de la Cavale Blanche

Brest, France

Centre Leon Berard

Lyon, France

Hopital Cochin

Paris, France

Hopital Europeen Georges-Pompidou

Paris, France

CHU Rouen Hopital Charles Nicolle

Rouen, France

Nouvel Hopital Civil - CHU Strasbourg

Strasbourg, France

Chungbuk National University Hospital

Cheongju-si, South Korea

Key Dates

Start Date

May 18, 2023

Primary Completion Date

March 29, 2024

Completion Date

July 30, 2026

Last Updated

March 16, 2026

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Dexamethasone

DRUG

Montelukast

DRUG

Methotrexate

DRUG

Amivantamab

DRUG

Lazertinib

DRUG

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NCT04165798

Carcinoma, Non-Small-Cell Lung

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Carcinoma, Non-Small-Cell Lung

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)