Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866 | Active Not Recruiting Phase 2 Results FDA Drug

• 4 other identifiers: CR10930561186372NSC20052022-000974-252023-506578-11-00
• Study Type: interventional
• Target: 68
• Locations: 5 countries
• Sites: 36

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1

  Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.

  Cycle 1 Day 1 (each cycle of 28 days)

Secondary Outcomes (8)

• Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1

  Cycle 1 Day 1 (each cycle of 28 days)

• Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)

  From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)

• Percentage of Participants With IRRs up to End of Treatment (EOT)

  From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months

• Percentage of Participants With Other Adverse Events (AEs): Non-IRRs

  From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months

• Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1

  Cycle 1 Day 1 (each cycle of 28 days)

Study Arms (1)

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

EXPERIMENTAL

Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.

Drug: Dexamethasone; Drug: Montelukast; Drug: Methotrexate; Drug: Amivantamab; Drug: Lazertinib

Interventions

Dexamethasone DRUG

Dexamethasone will be administered orally.

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Montelukast DRUG

Montelukast will be administered orally.

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Methotrexate DRUG

Methotrexate will be administered subcutaneously.

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Amivantamab DRUG

Amivantamab will be administered intravenously.

Also known as: JNJ-61186372

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Lazertinib DRUG

Lazertinib tablets will be administered orally.

Also known as: JNJ-73841937

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[or equivalent\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (36)

Compassionate Cancer Care

Fountain Valley, California, 92708, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

UW Medicine Valley Medical Center

Renton, Washington, 98055, United States

Location

CHU de Brest - Hopital de la Cavale Blanche

Brest, 29200, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Europeen Georges-Pompidou

Paris, 75015, France

Location

CHU Rouen Hopital Charles Nicolle

Rouen, 76000, France

Location

Nouvel Hopital Civil - CHU Strasbourg

Strasbourg, 67091, France

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. Quiron Dexeus

Barcelona, 8028, Spain

Location

Hosp. San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

Location

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, 08908, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp Virgen de La Victoria

Málaga, 29010, Spain

Location

Hosp. Univ. Son Espases

Palma de Mallorca, 07120, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Inst. Valenciano de Oncologia

Valencia, 46009, Spain

Location

Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

Location

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009, Spain

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chi-Mei Medical Center, Liouying

Tainan, 73657, Taiwan

Location

National Taiwan University Hospital

Taipei, 10043, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

• Spira AI, Paz-Ares L, Han JY, Shih JY, Mascaux C, Roy UB, Zugazagoitia J, Kim YJ, Chiu CH, Kim SW, Nadal E, Gil-Bazo I, Murphy SP, Anderson BG, Xia Y, Wang G, Bauml JM, Chioda M, Simoes J, Mahadevia PJ, Lopes G. Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report. J Thorac Oncol. 2025 Jun;20(6):809-816. doi: 10.1016/j.jtho.2025.01.018. Epub 2025 Jan 24.

  PMID: 39864547 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Dexamethasone; montelukast; Methotrexate; amivantamab; lazertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Medical Director Global Medical Affair Oncology
• Organization: Janssen Research & Development LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 23, 2022
• Study Start: May 18, 2023
• Primary Completion: March 29, 2024
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 8, 2026
• Results First Posted: October 20, 2025

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

TW (7); KR (6); US (3); ES (14); FR (6)