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OpenTrials
Completed

NCT Number: NCT01999673

Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

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Key information

Conditions

Non-Small-Cell Lung Cancer Stage IIIB Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small-Cell Lung Cancer Metastatic Non-Small-Cell Lung Cancer Stage IV Non-Small-Cell Lung Carcinoma Non-small Cell Lung Cancer Nonsmall Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peregrine Pharmaceuticals Investigational Site, Campbelltown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female at least 18 years of age
  • Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
  • Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal and hepatic function

Exclusion criteria

  • Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
  • Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
  • Cavitary tumors or tumors invading or abutting large blood vessels
  • Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
  • Grade 2 or higher peripheral neuropathy

Treatment and study plan

bavituximab

Biological

docetaxel

Drug

Other names: Taxotere

Placebo (for bavituximab)

Other

Primary outcomes

  1. Overall Survival

    Time frame: Approximately up to 36 months

Secondary outcomes

  1. Progression-free survival

    Time frame: Approximately up to 36 months

  2. Overall Response Rate

    Time frame: Approximately up to 36 months

  3. Safety

    Time frame: Approximately up to 36 months

    As measured by adverse event rates and laboratory evaluations

Sponsors and collaborators

Lead sponsor

Peregrine Pharmaceuticals

Industry

Registry information

Official study title

SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

Acronym: SUNRISE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2013
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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