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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: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Defined as ≤10% viable cancer cells in the surgical specimen, as assessed per central pathology laboratory post-surgery (IASLC method). Patients will only be considered to have an MPR if they also have an R0 margin result.
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
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2029-06-13 |
| Phase | Phase 3 |
What the registry record for NCT04351555 still lists
NCT04351555 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (45% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Where NCT04351555's enrollment target sits among peer trials
358 108th of 454 higher than 347 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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