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RECRUITING Phase 2

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Interventions

  • DRUG Carboplatin
  • DRUG Pemetrexed
  • DRUG Amivantamab
  • DRUG Lazertinib
  • DRUG Direct Oral Anticoagulant (DOAC)

Study Locations (20)

Florida

  • Baptist Lynn Cancer Institute — Boca Raton
  • Mount Sinai Medical Center — Miami Beach
  • AdventHealth — Orlando
  • H. Lee Moffitt Cancer & Research Institute — Tampa

California

  • University of California at San Diego — La Jolla
  • University of California Irvine — Orange
  • Stanford Cancer Institute — Stanford

Ohio

  • Cleveland Clinic — Cleveland
  • Cleveland Clinic — Cleveland
  • Cleveland Clinic — Mayfield Heights

New Jersey

  • Hackensack University Medical Center — Hackensack
  • Rutgers Cancer Institute of New Jersey — New Brunswick

North Carolina

  • Novant Health — Charlotte
  • Novant Health — Winston-Salem

District of Columbia

  • Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital — Washington D.C.

Kansas

  • University of Kansas Cancer Center — Westwood

Maryland

  • Sidney Kimmel Cancer Center - Bayview Campus — Baltimore

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2022-11-11
Est. Completion 2028-08-18
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05498428

The ClinicalTrials.gov registry entry for NCT05498428 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Carcinoma, Non-small-Cell Lung appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05498428 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05498428 about?

NCT05498428 is a clinical study titled "A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer". The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characteri...

What is the current status of trial NCT05498428?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 520 participants. The study started on 2022-11-11. Estimated completion is 2028-08-18.

What conditions does trial NCT05498428 study?

This clinical trial studies the following conditions: Carcinoma, Non-small-Cell Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05498428?

The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Amivantamab (DRUG), Lazertinib (DRUG), Direct Oral Anticoagulant (DOAC) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05498428?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05498428 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial