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NCT04077463 · ClinicalTrials.gov registry record · Phase 1

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.

Active
Registry status
Phase 1
Development phase
701
Enrollment target
20
Study locations

NCT04077463 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 701 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT04077463, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
701 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).

Conditions Studied

Carcinoma, Non-Small Cell Lung

Interventions

  • DRUG Carboplatin
  • DRUG Pemetrexed
  • DRUG Amivantamab
  • DRUG Lazertinib

Study Locations (20)

California

  • USC Norris Comprehensive Cancer Center - Los Angeles
  • University of California Irvine - Orange
  • UCSF Helen Diller Comprehensive - San Francisco
  • Stanford University Medical Center - Stanford
  • Cedars Sinai Medical Center - West Hollywood

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston
  • Boston University Medical Center - Boston

New York

  • Langone Health at NYC University, NYU School of Medicine - New York
  • Columbia University Medical Center - New York

Other

  • Beijing Cancer Hospital - Beijing
  • The First Bethune Hospital of Jilin University - Changchun

Florida

  • H. Lee Moffitt Cancer & Research Institute - Tampa

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit

Missouri

  • Washington University School Of Medicine - St Louis

Oregon

  • Providence Portland Medical Center - Portland

Trial Details

FieldValue
Enrollment Target 701 participants
Start Date 2019-09-04
Est. Completion 2028-03-27
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04077463

The ClinicalTrials.gov registry entry for NCT04077463 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 701 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (120% 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 Carboplatin is the first listed.

NCT04077463 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT04077463 about?

NCT04077463 is a clinical study titled "A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer". The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety ...

What is the current status of trial NCT04077463?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 701 participants. The study started on 2019-09-04. Estimated completion is 2028-03-27.

What conditions does trial NCT04077463 study?

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

What interventions are being tested in trial NCT04077463?

The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).

Who is sponsoring clinical trial NCT04077463?

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

Where is trial NCT04077463 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.