Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05663866 · ClinicalTrials.gov registry record · Phase 2
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT05663866: Active Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT05663866 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 68 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05663866, a Phase 2 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Montelukast
- DRUG Methotrexate
- DRUG Amivantamab
- DRUG Lazertinib
Study Locations (20)
Other
- CHU de Brest - Hopital de la Cavale Blanche - Brest
- Centre Leon Berard - Lyon
- Hopital Cochin - Paris
- Hopital Europeen Georges-Pompidou - Paris
- CHU Rouen Hopital Charles Nicolle - Rouen
- Nouvel Hopital Civil - CHU Strasbourg - Strasbourg
- Chungbuk National University Hospital - Cheongju-si
- National Cancer Center - Gyeonggi-do
- Gachon University Gil Medical Center - Incheon
- Chonnam National University Hwasun Hospital - Jeollanam-do
- Seoul National University Bundang Hospital - Seongnam-si
- Asan Medical Center - Seoul
- Hosp. de La Santa Creu I Sant Pau - Barcelona
- Hosp Univ Vall D Hebron - Barcelona
- Hosp. Univ. Quiron Dexeus - Barcelona
- Hosp. San Pedro de Alcantara - Cáceres
- Hosp. de Jerez de La Frontera - Jerez de la Frontera
California
- Compassionate Cancer Care - Fountain Valley
Virginia
- Virginia Cancer Specialists - Fairfax
Washington
- UW Medicine Valley Medical Center - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 2 |
What the registry record for NCT05663866 still lists
NCT05663866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT05663866 names 20 study sites across 4 states, led by Other, California, Virginia.
Frequently Asked Questions
What is clinical trial NCT05663866 about?
NCT05663866 is a clinical study titled "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.
What is the current status of trial NCT05663866?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2023-05-18. Estimated completion is 2026-07-30.
What conditions does trial NCT05663866 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT05663866?
The interventions under investigation include: Dexamethasone (DRUG), Montelukast (DRUG), Methotrexate (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT05663866?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05663866 being conducted?
This trial has 20 study locations across California, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Non-Small Cell Lung
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05663866's enrollment target sits among peer trials
68 86th of 130 higher than 45 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer
RECRUITING · Phase 2
-
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
RECRUITING · Phase 2
-
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
RECRUITING · Phase 2
-
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
RECRUITING · Phase 2
-
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
RECRUITING · Phase 2
-
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02044497 · 68 participants · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
- NCT03779854 · 68 participants · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
- NCT03821246 · 68 participants · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
- NCT04115514 · 68 participants · Phase 2
Treatment of ARDS With Instilled T3
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI