NCT01999673|CompletedPhase 3DMC

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

SUNRISE

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

Peregrine Pharmaceuticals ClinicalTrials.gov

Compare

2 other identifiers

PPHM 12022013-003953-13

Study Type

interventional

Target

582

Locations

14 countries

Sites

161

Timeline

RegisteredDec 2013

StartedDec 2013

CompletionMar 2017

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

582

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2013

Typical duration for phase_3

Geographic Reach

14 countries

161 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

November 25, 2013

Completed

6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed

Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

November 25, 2013

Last Update Submit

April 19, 2017

Conditions

Non-Small-Cell Lung Cancer Stage IIIB Non-Small-Cell Lung Cancer Stage IV Non-Small-Cell Lung Cancer Metastatic Carcinoma, Non-Small-Cell Lung Nonsmall Cell Lung Cancer Non-Small-Cell Lung Carcinoma

Keywords

SUNRISEPPHM 1202BavituximabPeregrine

Outcome Measures

Primary Outcomes (1)

Overall Survival
Approximately up to 36 months

Secondary Outcomes (3)

Progression-free survival
Approximately up to 36 months
Overall Response Rate
Approximately up to 36 months
Safety
Approximately up to 36 months

Study Arms (2)

bavituximab plus docetaxel

EXPERIMENTAL

Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.

Biological: bavituximabDrug: Docetaxel

placebo plus docetaxel

PLACEBO COMPARATOR

Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.

Drug: DocetaxelOther: Placebo (for bavituximab)

Interventions

bavituximabBIOLOGICAL

bavituximab plus docetaxel

DocetaxelDRUG

Also known as: Taxotere

bavituximab plus docetaxelplacebo plus docetaxel

Placebo (for bavituximab)OTHER

placebo plus docetaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.