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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 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 335-participant average among 7 other Non-squamous Non-small Cell Lung Cancer trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 8 states.

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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.

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

FieldValue
Enrollment Target 485 participants
Start Date 2011-06-25
Est. Completion 2016-06-25
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01351415

The ClinicalTrials.gov registry entry for NCT01351415 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 485 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 335-participant average among 7 other Non-squamous Non-small Cell Lung Cancer trials with a reported enrollment target (45% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.