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Active, Not Recruiting

NCT Number: NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Brest - Hopital de la Cavale Blanche, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone will be administered orally.

Montelukast

Drug

Montelukast will be administered orally.

methotrexate

Drug

Methotrexate will be administered subcutaneously.

Amivantamab

Drug

Amivantamab will be administered intravenously.

Other names: JNJ-61186372

Lazertinib

Drug

Lazertinib tablets will be administered orally.

Other names: JNJ-73841937

Primary outcomes

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

    Time frame: Cycle 1 Day 1 (each cycle of 28 days)

    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.

Secondary outcomes

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

    Time frame: Cycle 1 Day 1 (each cycle of 28 days)

  2. 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)

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

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

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

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

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

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

    Time frame: Cycle 1 Day 1 (each cycle of 28 days)

  6. Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1

    Time frame: Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)

  7. Overall Response Rate (ORR)

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

  8. Duration of Response (DOR)

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Dec 23, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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