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NCT04606771 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT04606771: Active Phase 2 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
NCT04606771 is a Phase 2 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 30 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606771, a Phase 2 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.
Primary Outcome
Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesions. Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- DRUG Osimertinib + Savolitinib
- DRUG Savolitinib + Placebo
Study Locations (20)
Other
- Research Site - Ciudad de Buenos Aires
- Research Site - Delhi
- Research Site - Mumbai
- Research Site - Taichung
- Research Site - Taipei
- Research Site - Taipei
- Research Site - Taipei
- Research Site - Taoyuan
- Research Site - Bangkok
- Research Site - Bangkok
- Research Site - Bangkok
- Research Site - Bangkok
- Research Site - Bangkok
- Research Site - Hat Yai
- Research Site - Khon Kaen
- Research Site - Muang
- Research Site - Hanoi
- Research Site - Hà Nội
California
- Research Site - Duarte
- Research Site - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What the registry record for NCT04606771 still lists
NCT04606771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib + Savolitinib is the first listed.
NCT04606771 names 20 study sites across 2 states, led by Other, California.
Frequently Asked Questions
What is clinical trial NCT04606771 about?
NCT04606771 is a clinical study titled "A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC". This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer w...
What is the current status of trial NCT04606771?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2020-09-28. Estimated completion is 2026-03-30.
What conditions does trial NCT04606771 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04606771?
The interventions under investigation include: Osimertinib + Savolitinib (DRUG), Savolitinib + Placebo (DRUG).
Who is sponsoring clinical trial NCT04606771?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04606771 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04606771's enrollment target sits among peer trials
30 387th of 454 higher than 58 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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