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Amivantamab / Dexamethasone / Methotrexate · Phase 2 Trial
ClinicalTrials.gov · July 31, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration evaluating three premedication strategies (dexamethasone, montelukast, methotrexate) to reduce first-dose infusion-related reactions with amivantamab in non-small-cell lung cancer. No results are reported in this registry record; the study is actively recruiting or closed to recruitment but outcomes remain unpublished.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Carcinoma, Non-Small-Cell Lung; age from 18 Years. Intervention: Background Anti-cancer Therapy with Amivantamab Plus Lazert…. n = 68. 36 sites across 5 countries.
This is a Phase 2 trial registration evaluating three premedication strategies (dexamethasone, montelukast, methotrexate) to reduce first-dose infusion-related reactions with amivantamab in non-small-cell lung cancer. No results are reported in this registry record; the study is actively recruiting or closed to recruitment but outcomes remain unpublished.
No results are reported in this registry record; outcomes and safety data are not yet available. Primary endpoint is reported as percentage with IRRs at a single timepoint (Cycle 1 Day 1); longer-term safety and comparative efficacy between premedication arms unclear.
If results support premedication efficacy, this could establish a clinical protocol to reduce infusion-related toxicity and improve amivantamab tolerability. Clinicians should await formal publication of outcomes before adopting any new premedication regimen.
This is an active interventional Phase 2 trial registry record with no results reported; it describes a planned study of premedication strategies to reduce amivantamab infusion reactions in non-small-cell lung cancer.
As stated by the source record.
Quoted from the source exactly as published.
If results support premedication efficacy, this could establish a clinical protocol to reduce infusion-related toxicity and improve amivantamab tolerability. Clinicians should await formal publication of outcomes before adopting any new premedication regimen.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05663866). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 68 participants (ACTUAL). Conditions: Carcinoma, Non-Small-Cell Lung. Interventions: DRUG: Dexamethasone; DRUG: Montelukast; DRUG: Methotrexate; DRUG: Amivantamab; DRUG: Lazertinib. Primary outcome measures: Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1 , Cycle 1 Day 1 (each cycle of 28 days). 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.