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Carcinoma, Non-Small-Cell LungPhase 2NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

A Phase 2 study testing Dexamethasone, Montelukast and Methotrexate in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 36 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Dexamethasone, Montelukast and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
36 sitesin 5 countries
Study dates
18 May 2023to 30 Sep 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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])

Who cannot join

  • 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

Trial locations and contacts

36 sites in 5 countries.

36 sites in 5 countries

Spain14 sites

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 8028

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Hosp. Univ. Son Espases

    Palma de Mallorca, 07120

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Inst. Valenciano de Oncologia

    Valencia, 46009

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi-Mei Medical Center, Liouying

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 10043

  • Taipei Medical University

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

France6 sites

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest, 29200

  • Centre Leon Berard

    Lyon, 69008

  • Hopital Cochin

    Paris, 75014

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • CHU Rouen Hopital Charles Nicolle

    Rouen, 76000

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091

Other trials in France

South Korea6 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • National Cancer Center

    Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

United States3 sites

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Compassionate Cancer Care

    Fountain Valley, California, 92708

  • UW Medicine Valley Medical Center

    Renton, Washington, 98055

Other trials in United States

About this study

Official 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

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.

Being tested
Dexamethasone, Montelukast, Methotrexate, Amivantamab, Lazertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Dexamethasone will be administered orally.

  • MontelukastDrug

    Montelukast will be administered orally.

  • MethotrexateDrug

    Methotrexate will be administered subcutaneously.

  • AmivantamabDrug

    Also called JNJ-61186372

    Amivantamab will be administered intravenously.

  • LazertinibDrug

    Also called JNJ-73841937

    Lazertinib tablets will be administered orally.

Study groups in NCT05663866
Study groupRoleWhat they receive
Background Anti-cancer Therapy with Amivantamab Plus LazertinibExperimentalParticipant 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.
Receives: Drug: Dexamethasone; Drug: Montelukast; Drug: Methotrexate; Drug: Amivantamab; Drug: Lazertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Cycle 1 Day 1 (each cycle of 28 days)

Secondary outcomes (8)

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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: Cycle 1 Day 1 (each cycle of 28 days)

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

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

  7. Overall Response Rate (ORR)

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

  8. Duration of Response (DOR)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start18 May 2023
  3. Primary completion29 Mar 2024
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663866
Sponsor's protocol ID
CR109305
Other IDs
61186372NSC2005, 2022-000974-25, 2023-506578-11-00, 2023
Status last verified
Nov 2026
First submitted
16 Dec 2022
Last updated
3 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • 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.

    PubMed 39864547

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Montelukast and Methotrexate in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 36 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Spain, Taiwan, France, South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1 (time frame: Cycle 1 Day 1 (each cycle of 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663866, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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