Clinical trial · Interventional
Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small-Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non-Small-Cell Lung Cancer Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-Small-Cell Lung Cancer Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bavituximab | Biological | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Placebo (for bavituximab) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- bavituximab plus docetaxel
- description
- Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
- interventionNames
- Biological: bavituximab
- Drug: Docetaxel
- type
- PLACEBO_COMPARATOR
- label
- placebo plus docetaxel
- description
- Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
- interventionNames
- Drug: Docetaxel
- Other: Placebo (for bavituximab)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGerber 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. PMID 29767677