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

ClinicalTrials.gov ID: NCT04351555

Public ClinicalTrials.gov record NCT04351555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT04351555
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 358 participants

Conditions and interventions

Conditions

Non-Small Cell Lung Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 16, 2020 (Actual)
Primary completion: Oct 15, 2024 (Actual)
Completion: Jun 13, 2029 (Estimated)
Last update posted: Sep 9, 2026

2020 – 2029

United States locations

U.S. sites: 12
U.S. states: 7
U.S. cities: 12

Facility	City	State	ZIP	Site status
Research Site	Duarte	California	91010	—
Research Site	Irvine	California	92618	—
Research Site	San Francisco	California	94143	—
Research Site	Santa Monica	California	90404	—
Research Site	Santa Rosa	California	95403	—
Research Site	Boston	Massachusetts	02215	—
Research Site	Lebanon	New Hampshire	03756	—
Research Site	Commack	New York	11725	—
Research Site	New York	New York	10032	—
Research Site	Houston	Texas	77030	—
Research Site	Fairfax	Virginia	22031	—
Research Site	Seattle	Washington	98104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 146 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04351555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 9, 2026 · Synced Nov 9, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04351555 live on ClinicalTrials.gov.

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