Phase 4
Completed N=2,252
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Source: ClinicalTrials.gov NCT00451906 ↗Enrolled (actual)
2,252
Serious AEs
37.7%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Adverse Events of Special Interest — 687; 672; 26; 30 participants
◆ Published Evidence
Highly cited
267citations · ~17 / year
Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study.
Summary
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
Linked Publications (2)
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Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study.
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First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events of Special Interest |
687; 672; 26; 30; 274; 176 | — |
| PRIMARY Number of Participants With Serious Adverse Events Related to Bevacizumab |
283 | — |
| SECONDARY Duration of Overall Survival |
14.6 | — |
| SECONDARY Time to Disease Progression |
7.8 | — |
| SECONDARY Number of Participants With Central Nervous System Bleeding |
12; 16 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
- ECOG PS status 0-2;
- life expectancy >= 12weeks;
- adequate renal, liver and hematological function.
Exclusion Criteria
- mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
- hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
- evidence of tumor invading major blood vessels on imaging;
- evidence of CNS metastases, even if previously treated.
- major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
- prior chemotherapy for stage IIIb/IV disease.
Data sourced from ClinicalTrials.gov (NCT00451906) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.