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NCT03381274 · ClinicalTrials.gov registry record · Phase 1
Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by MedImmune.
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 13
- Study locations
NCT03381274: Active Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by MedImmune.
NCT03381274 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by MedImmune. The registered enrollment target is 43 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (87% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03381274, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by MedImmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 13
- Study locations
Study Summary
The objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced EGFRm NSCLC.
Primary Outcome
A DLT was defined as \>= Grade 3 toxicity or adverse events (AE) occurred during DLT evaluation period which included any Grade 4 immune-mediated (immune nature) AE, anemia, thrombocytopenia (present \> 4 days), or neutropenia (present \> 4 days); \>= Grade 3 colitis or pneumonitis or interstitial lung disease (ILD); \>= Grade 3 nausea, vomiting, or diarrhea (not resolved to \<= Grade 2 in 3 days); Grade 2 pneumonitis or ILD (not resolved to \<= Grade 1 in 3 days); Grade 3 thrombocytopenia with
Conditions Studied
Interventions
- DRUG Osimertinib
- BIOLOGICAL Oleclumab
- DRUG AZD4635
Study Locations (13)
Other
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Taichung
California
- Research Site - La Jolla
- Research Site - San Francisco
Colorado
- Research Site - Aurora
Connecticut
- Research Site - New Haven
Georgia
- Research Site - Atlanta
Illinois
- Research Site - Chicago
Maryland
- Research Site - Baltimore
New York
- Research Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-05-08 |
| Est. Completion | 2026-04-16 |
| Phase | Phase 1 |
What the registry record for NCT03381274 still lists
NCT03381274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Osimertinib is the first listed.
NCT03381274 lists 13 locations in 9 states (Other, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03381274 about?
NCT03381274 is a clinical study titled "Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study". The objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced EGFRm NSCLC.
What is the current status of trial NCT03381274?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-05-08. Estimated completion is 2026-04-16.
What conditions does trial NCT03381274 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03381274?
The interventions under investigation include: Osimertinib (DRUG), Oleclumab (BIOLOGICAL), AZD4635 (DRUG).
Who is sponsoring clinical trial NCT03381274?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03381274 being conducted?
This trial has 13 study locations across California, Colorado, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03381274's enrollment target sits among peer trials
43 97th of 130 higher than 33 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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