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NCT02088112 · ClinicalTrials.gov registry record · Phase 1
MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 7
- Study locations
NCT02088112: Completed Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by MedImmune.
NCT02088112 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that has completed, run by MedImmune. The registered enrollment target is 56 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (83% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088112, a Phase 1 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 7
- Study locations
Study Summary
This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects
Primary Outcome
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]; Safety Labs: Blood and urine samples for determination of clinical chemistry, hematology, coagulation, thyroid function tests and urinalysis will be taken at the visits; any laboratory abnormalities, and including dose-limiting toxicities (DLTs), ECG measurements and Creatinine Clearance
Conditions Studied
Interventions
- DRUG Gefitinib
- DRUG MEDI4736
Study Locations (7)
Other
- Research Site - Chūōku
- Research Site - Matsuyama
- Research Site - Seoul
- Research Site - Seoul
Florida
- Research Site - Tampa
Texas
- Research Site - Houston
Washington
- Research Site - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2014-03-24 |
| Est. Completion | 2021-03-09 |
| Phase | Phase 1 |
What the finished NCT02088112 record still lists
NCT02088112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Gefitinib is the first listed.
NCT02088112 lists 7 locations in 4 states (Other, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT02088112 about?
NCT02088112 is a clinical study titled "MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).". This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and a...
What is the current status of trial NCT02088112?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2014-03-24. Estimated completion is 2021-03-09.
What conditions does trial NCT02088112 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT02088112?
The interventions under investigation include: Gefitinib (DRUG), MEDI4736 (DRUG).
Who is sponsoring clinical trial NCT02088112?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02088112 being conducted?
This trial has 7 study locations across Florida, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02088112's enrollment target sits among peer trials
56 91st of 130 higher than 40 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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