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NCT03778229 · ClinicalTrials.gov registry record · Phase 2
Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
A Phase 2 study of Carcinoma, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 367
- Enrollment target
- 20
- Study locations
NCT03778229: Active Phase 2 study of Carcinoma, sponsored by AstraZeneca.
NCT03778229 is a Phase 2 study of Carcinoma that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 367 participants, above the 242-participant average among 29 other Carcinoma trials with a reported enrollment target (52% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03778229, a Phase 2 study of Carcinoma, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 367 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib
Primary Outcome
Percentage of subjects with a confirmed Objective Response (OR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). OR includes Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in target lesion diameters). OR must be recorded at one visit and confirmed by repeat imaging at least 4 weeks later, with no disease progression between initial and confirmation visits.
Conditions Studied
Interventions
- DRUG placebo
- DRUG osimertinib
- DRUG savolitinib
Study Locations (20)
Other
- Research Site - Barretos
- Research Site - Curitiba
- Research Site - Goiânia
- Research Site - Porto Alegre
- Research Site - Porto Alegre
- Research Site - Rio de Janeiro
- Research Site - Salvador
- Research Site - São José do Rio Preto
- Research Site - São Paulo
California
- Research Site - La Jolla
- Research Site - Los Angeles
- Research Site - Sacramento
Pennsylvania
- Research Site - Philadelphia
- Research Site - Pittsburgh
District of Columbia
- Research Site - Washington D.C.
Maryland
- Research Site - Baltimore
Massachusetts
- Research Site - Boston
Minnesota
- Research Site - Rochester
New York
- Research Site - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03778229 still lists
NCT03778229 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, above the 242-participant average among 29 other Carcinoma trials with a reported enrollment target (52% higher).
The record links to 1 condition, with Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT03778229 names 20 study sites across 9 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03778229 about?
NCT03778229 is a clinical study titled "Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib". This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib
What is the current status of trial NCT03778229?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 367 participants. The study started on 2019-01-09. Estimated completion is 2026-12-31.
What conditions does trial NCT03778229 study?
This clinical trial studies the following conditions: Carcinoma.
What interventions are being tested in trial NCT03778229?
The interventions under investigation include: placebo (DRUG), osimertinib (DRUG), savolitinib (DRUG).
Who is sponsoring clinical trial NCT03778229?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03778229 being conducted?
This trial has 20 study locations across California, District of Columbia, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03778229's enrollment target sits among peer trials
367 6th of 29 higher than 24 of 29 other Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma 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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