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NCT04487080 · ClinicalTrials.gov registry record · Phase 3

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.

Active
Registry status
Phase 3
Development phase
1,074
Enrollment target
20
Study locations

NCT04487080 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 1,074 participants, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (240% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT04487080, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,074 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Interventions

  • DRUG Placebo
  • DRUG Osimertinib
  • DRUG Amivantamab
  • DRUG Lazertinib

Study Locations (20)

Arizona

  • Arizona Oncology Associates, PC - HAL - Goodyear
  • Yuma Regional Medical Center - Yuma

California

  • City of Hope Long Beach Elm - Long Beach
  • University of California Irvine - Orange

Minnesota

  • Minnesota Oncology Hematology P A - Edina
  • Mayo Clinic - Rochester

Texas

  • Texas Oncology P A - Austin
  • Oncology Consultants Texas - Houston

Colorado

  • Rocky Mountain Cancer Centers - Lone Tree

Florida

  • Cancer Specialists of North Florida - Jacksonville

Georgia

  • University Cancer And Blood Center LLC - Athens

Louisiana

  • East Jefferson General Hospital - Metairie

Trial Details

FieldValue
Enrollment Target 1,074 participants
Start Date 2020-09-30
Est. Completion 2027-06-29
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT04487080

The ClinicalTrials.gov registry entry for NCT04487080 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,074 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (240% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT04487080 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Arizona, California, Minnesota.

Frequently Asked Questions

What is clinical trial NCT04487080 about?

NCT04487080 is a clinical study titled "A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer". The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastati...

What is the current status of trial NCT04487080?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,074 participants. The study started on 2020-09-30. Estimated completion is 2027-06-29.

What conditions does trial NCT04487080 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT04487080?

The interventions under investigation include: Placebo (DRUG), Osimertinib (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).

Who is sponsoring clinical trial NCT04487080?

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

Where is trial NCT04487080 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.