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NCT05498428 · ClinicalTrials.gov registry record · 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

A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 2
Development phase
520
Enrollment target
20
Study locations

NCT05498428: Recruiting Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.

NCT05498428 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 520 participants, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (63% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05498428, a Phase 2 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 2
Development phase
520 participants
Enrollment target
20
Study locations

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).

Primary Outcome

ORR based on INV will be reported. ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.

Conditions Studied

Carcinoma, Non-Small Cell Lung

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
Janssen Research & Development

593 total trials

What NCT05498428 shows while recruiting

NCT05498428 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (63% higher).

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.

NCT05498428 names 20 study sites across 11 states, led by Florida, California, Ohio.

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.

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).

Who is sponsoring clinical trial NCT05498428?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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.

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 NCT05498428's enrollment target sits among peer trials

520 28th of 130 higher than 103 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

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More recruiting context for NCT05498428

Source: ClinicalTrials.gov NCT05498428, the US trial registry maintained by the National Library of Medicine. NCT05498428 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.