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NCT03833154 · ClinicalTrials.gov registry record · Phase 3
Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 724
- Enrollment target
- 20
- Study locations
NCT03833154 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 724 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (128% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT03833154, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 724 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Durvalumab
- DRUG (Osimertinib cohort, single-arm, open-label separate cohort)
Study Locations (20)
California
- Research Site - Duarte
- Research Site - Long Beach
- Research Site - Los Angeles
- Research Site - San Diego
Florida
- Research Site - Bay Pines
- Research Site - Jacksonville
- Research Site - Miami Beach
- Research Site - Orlando
Illinois
- Research Site - Chicago
- Research Site - Chicago
- Research Site - Chicago
- Research Site - Decatur
Arizona
- Research Site - Chandler
- Research Site - Phoenix
- Research Site - Tucson
Georgia
- Research Site - Atlanta
- Research Site - Atlanta
Alabama
- Research Site - Tuscaloosa
Delaware
- Research Site - Newark
District of Columbia
- Research Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 724 participants |
| Start Date | 2019-03-06 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03833154
The ClinicalTrials.gov registry entry for NCT03833154 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 724 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 (128% higher). The listed sponsor is AstraZeneca, which has 1,285 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 3 interventions - of which Placebo is the first listed.
NCT03833154 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03833154 about?
NCT03833154 is a clinical study titled "Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation". This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess...
What is the current status of trial NCT03833154?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2019-03-06. Estimated completion is 2028-10-31.
What conditions does trial NCT03833154 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03833154?
The interventions under investigation include: Placebo (OTHER), Durvalumab (DRUG), (Osimertinib cohort, single-arm, open-label separate cohort) (DRUG).
Who is sponsoring clinical trial NCT03833154?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03833154 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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