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NCT02810457 · ClinicalTrials.gov registry record · Phase 3
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Centus Biotherapeutics Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 731
- Enrollment target
- 20
- Study locations
NCT02810457: Completed Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Centus Biotherapeutics Limited.
NCT02810457 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that has completed, run by Centus Biotherapeutics Limited. The registered enrollment target is 731 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02810457, a Phase 3 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Centus Biotherapeutics Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 731 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer
Primary Outcome
The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the init
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG FKB238 (bevacizumab)
- DRUG Avastin (bevacizumab)
Study Locations (20)
Ohio
- Research Site 7805 - Hematology & Oncology Associates, Inc. - Canton
- Research Site 7801 - Gabrail Cancer Center - Canton
- Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc. - Massillon
California
- Research Site 7814 - Compassionate Care Research Group - Fountain Valley
- Research Site 7811 - Innovative Clinical Research Institute - Whittier
Illinois
- Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd. - Joliet
- Research Site 7810 - Edward H. Kaplan, MD and Associates - Skokie
Minsk Oblast
- Research Site 8501 - Lyasny
- Research Site 8504 - Minsk
Other
- Research Site 8606 - Banja Luka
- Research Site 8602 - Mostar
Florida
- Research Site 7803 - 21st Century Oncology - Jacksonville
North Dakota
- Research Site 7813 - Trinity Cancer Care Center - Minot
Texas
- Research Site 7809 - Millennium Oncology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 731 participants |
| Start Date | 2016-09-07 |
| Est. Completion | 2022-01-26 |
| Phase | Phase 3 |
What the finished NCT02810457 record still lists
NCT02810457 is an interventional study that assigns participants to a tested intervention. The registered 731 participants enrollment target is mid-sized for trials with a published cap, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (130% higher).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT02810457 names 20 study sites across 14 states, led by Ohio, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02810457 about?
NCT02810457 is a clinical study titled "Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer". The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer
What is the current status of trial NCT02810457?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 731 participants. The study started on 2016-09-07. Estimated completion is 2022-01-26.
What conditions does trial NCT02810457 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT02810457?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), FKB238 (bevacizumab) (DRUG), Avastin (bevacizumab) (DRUG).
Who is sponsoring clinical trial NCT02810457?
This trial is sponsored by Centus Biotherapeutics Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02810457 being conducted?
This trial has 20 study locations across California, Florida, Illinois, North Dakota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Non-Small Cell Lung
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 NCT02810457's enrollment target sits among peer trials
731 13th of 130 higher than 118 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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