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NCT04351555 · ClinicalTrials.gov registry record · Phase 3

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
358
Enrollment target
20
Study locations

NCT04351555 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 358 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT04351555, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
358 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Conditions Studied

Interventions

  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Cisplatin
  • DRUG Osimertinib
  • DRUG Pemetrexed

Study Locations (20)

Other

  • Research Site - Graz
  • Research Site - Vienna
  • Research Site - Barretos
  • Research Site - Fortaleza
  • Research Site - Jaú
  • Research Site - Porto Alegre
  • Research Site - Porto Alegre
  • Research Site - Recife

California

  • Research Site - Duarte
  • Research Site - Irvine
  • Research Site - San Francisco
  • Research Site - Santa Monica
  • Research Site - Santa Rosa

New York

  • Research Site - Commack
  • Research Site - New York

Massachusetts

  • Research Site - Boston

New Hampshire

  • Research Site - Lebanon

Texas

  • Research Site - Houston

Virginia

  • Research Site - Fairfax

Washington

  • Research Site - Seattle

Trial Details

FieldValue
Enrollment Target 358 participants
Start Date 2020-12-16
Est. Completion 2029-06-13
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04351555

The ClinicalTrials.gov registry entry for NCT04351555 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (46% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT04351555 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT04351555 about?

NCT04351555 is a clinical study titled "A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer". This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

What is the current status of trial NCT04351555?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2020-12-16. Estimated completion is 2029-06-13.

What conditions does trial NCT04351555 study?

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

What interventions are being tested in trial NCT04351555?

The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Cisplatin (DRUG), Osimertinib (DRUG), Pemetrexed (DRUG).

Who is sponsoring clinical trial NCT04351555?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04351555 being conducted?

This trial has 20 study locations across California, Massachusetts, New Hampshire, New York, Texas. 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.