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NCT01351415 · ClinicalTrials.gov registry record · Phase 3
A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study of Non-squamous Non-small Cell Lung Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 485
- Enrollment target
- 20
- Study locations
NCT01351415: Completed Phase 3 study of Non-squamous Non-small Cell Lung Cancer, sponsored by Hoffmann-La Roche.
NCT01351415 is a Phase 3 study of Non-squamous Non-small Cell Lung Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 485 participants, above the 344-participant average among 9 other Non-squamous Non-small Cell Lung Cancer trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01351415, a Phase 3 study of Non-squamous Non-small Cell Lung Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 485 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.
Primary Outcome
Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Docetaxel
- DRUG Pemetrexed
- DRUG Erlotinib
Study Locations (20)
California
- East Valley Hematology ; Oncology Medical Group - Burbank
- California Cancer Associates for Research & Excellence, Inc. - Encinitas
- Scripps Clinic; Hematology & Oncology - La Jolla
- Sutter Cancer Center - Sacramento
- Coastal Integrative Cancer Care - San Luis Obispo
- Innovative Clinical Research Institute - Whittier
Florida
- Lynn Cancer Institute - West - Boca Raton
- Baptist - MD Anderson Cancer Center - Jacksonville
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) - Jacksonville
- Mount Sinai Medical Center - Miami Beach
- Cancer Care Centers of Brevard - Rockledge
Arizona
- Palo Verde Hema/Onc - Glendale
- Arizona Center for Cancer Care - Glendale
Connecticut
- The Hospital of Central CT - New Britain
- Eastern Ct Hema/Onco Assoc; Dept of Oncology - Norwich
Georgia
- Emory Univ Winship Cancer Inst - Atlanta
- Summit Cancer Care PC - Savannah
Alabama
- USA Mitchell Cancer Institute - Mobile
Arkansas
- Clopton Clinic - Jonesboro
Idaho
- Kootenai Cancer Center - Post Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2011-06-25 |
| Est. Completion | 2016-06-25 |
| Phase | Phase 3 |
What the finished NCT01351415 record still lists
NCT01351415 is an interventional study that assigns participants to a tested intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap, above the 344-participant average among 9 other Non-squamous Non-small Cell Lung Cancer trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Non-squamous Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT01351415 names 20 study sites across 8 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01351415 about?
NCT01351415 is a clinical study titled "A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)". This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6...
What is the current status of trial NCT01351415?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2011-06-25. Estimated completion is 2016-06-25.
What conditions does trial NCT01351415 study?
This clinical trial studies the following conditions: Non-squamous Non-small Cell Lung Cancer.
What interventions are being tested in trial NCT01351415?
The interventions under investigation include: Bevacizumab (DRUG), Docetaxel (DRUG), Pemetrexed (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01351415?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01351415 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01351415's enrollment target sits among peer trials
485 4th of 9 higher than 6 of 9 other Non-squamous Non-small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-squamous 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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