Clinical trial · Interventional
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
NCT00403403CI-TRIAL-00004746completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo+Chemotherapy
- description
- Chemotherapy = cisplatin (or carboplatin) + etoposide
- interventionNames
- Drug: Chemotherapy
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Bevacizumab+Chemotherapy
- description
- Chemotherapy = cisplatin (or carboplatin) + etoposide
- interventionNames
- Drug: Bevacizumab
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease * Measurable disease or lesions * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Exclusion Criteria: * Life expectancy of \< 12 weeks * Current, recent, or planned participation in another experimental drug study * Ongoing or active infection * Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years * Prior systemic therapy, radiation therapy, or surgery for SCLC * Inadequate bone marrow function, renal function, or hepatic function * Serum sodium of \< 120 mg/dL * Inadequately controlled hypertension * History of hypertensive crisis or hypertensive encephalopathy * New York Heart Association Class II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to study enrollment * History of stroke or transient ischemic attack within 6 months prior to study enrollment * Known central nervous system disease, except for brain metastases treated with whole-brain radiotherapy * Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to study enrollment * History of hemoptysis within 4 weeks prior to study enrollment * Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of a need for a major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1 * History of abdominal fistula or gastrointestinal perforation within 6 months prior to study enrollment * Serious, non-healing wound, active ulcer, or untreated bone fracture * Known hypersensitivity to any component of bevacizumab * Pregnant (positive pregnancy test) or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.