Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study aims to stop severe reactions to cancer infusion therapy

NCT ID NCT05663866

Prevention Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This phase 2 study tests whether giving dexamethasone, montelukast, or methotrexate before an amivantamab infusion can reduce or prevent infusion-related reactions in people with a type of advanced lung cancer (EGFR-mutant non-small cell lung cancer). The study enrolled 68 participants who had previously been treated with osimertinib. The goal is to make the infusion safer and more tolerable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Started

May 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Carcinoma, non-small-cell lung are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • CHU Rouen Hopital Charles Nicolle

    Rouen, 76000, France

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest, 29200, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Chi-Mei Medical Center, Liouying

    Tainan, 73657, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Compassionate Cancer Care

    Fountain Valley, California, 92708, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Hopital Cochin

    Paris, 75014, France

  • Hopital Europeen Georges-Pompidou

    Paris, 75015, France

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014, Spain

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 8028, Spain

  • Hosp. Univ. Son Espases

    Palma de Mallorca, 07120, Spain

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908, Spain

  • Inst. Valenciano de Oncologia

    Valencia, 46009, Spain

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Taiwan University Hospital

    Taipei, 10043, Taiwan

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091, France

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Medical University

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • UW Medicine Valley Medical Center

    Renton, Washington, 98055, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.