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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01999673




Registration number
NCT01999673
Ethics application status
Date submitted
25/11/2013
Date registered
3/12/2013
Date last updated
21/04/2017

Titles & IDs
Public title
Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
2013-003953-13
Secondary ID [2] 0 0
PPHM 1202
Universal Trial Number (UTN)
Trial acronym
SUNRISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Cancer Stage IIIB 0 0
Non-Small-Cell Lung Cancer Stage IV 0 0
Non-Small-Cell Lung Cancer Metastatic 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Non-Small Cell Lung Cancer 0 0
Non-Small-Cell Lung Carcinoma 0 0
Nonsmall Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: bavituximab plus docetaxel - Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.

Placebo comparator: placebo plus docetaxel - Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Approximately up to 36 months
Secondary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Approximately up to 36 months
Secondary outcome [2] 0 0
Overall Response Rate
Timepoint [2] 0 0
Approximately up to 36 months
Secondary outcome [3] 0 0
Safety
Timepoint [3] 0 0
Approximately up to 36 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
582
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Peregrine Pharmaceuticals Investigational Site - Campbelltown
Recruitment hospital [2] 0 0
Peregrine Pharmaceuticals Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Peregrine Pharmaceuticals Investigational Site - Tweed Heads
Recruitment hospital [4] 0 0
Peregrine Pharmaceuticals Investigational Site - Milton
Recruitment hospital [5] 0 0
Peregrine Pharmaceuticals Investigational Site - Redcliffe
Recruitment hospital [6] 0 0
Peregrine Pharmaceuticals Investigational Site - Elizabeth Vale
Recruitment hospital [7] 0 0
Peregrine Pharmaceuticals Investigational Site - Toorak Gardens
Recruitment hospital [8] 0 0
Peregrine Pharmaceuticals Investigational Site - Geelong
Recruitment hospital [9] 0 0
Peregrine Pharmaceuticals Investigational Site - Wodonga
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
4064 - Milton
Recruitment postcode(s) [5] 0 0
4020 - Redcliffe
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3690 - Wodonga
Recruitment outside Australia
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United States of America
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Kyiv
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Lutsk
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Ukraine
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Uzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Peregrine Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01999673
Trial related presentations / publications
Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01999673