N/A
Completed N=996
Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants
Source: ClinicalTrials.gov NCT02596958 ↗Enrolled (actual)
996
Serious AEs
11.1%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs — 88.6; 88.2; 27.0; 11.1 percentage of participants
Summary
The purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs |
88.6; 88.2; 27.0; 11.1 | — |
| SECONDARY Percentage of Participants Who Withdrew or Modified Treatment |
8.8 | — |
| SECONDARY Number of Cycles of Systemic Therapy |
7.6; 4.2; 3.4 | — |
| SECONDARY Percentage of Participants With Best Tumor Response Over Time |
2.3; 43.3; 29.4; 10.1; 14.9 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades |
18.7; 50.1; 23.2; 6.2; 1.7 | — |
| SECONDARY Percentage of Participants With Disease Control |
75.0 | — |
| SECONDARY Progression Free Survival (PFS) |
7.4 | — |
| SECONDARY Percentage of Participants Who Died |
17.5 | — |
| SECONDARY Overall Survival |
18.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to (>=) 18 years
- Histologically confirmed predominantly non-squamous NSCLC that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma)
- No contraindications to Avastin® according to the current Summary of Product Characteristics (SmPC) for Avastin®
- Therapeutic decision for Avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial.
Exclusion Criteria
N/A
Data sourced from ClinicalTrials.gov (NCT02596958). 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.