Phase 3
Completed N=913
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Carcinoma · Non Small Cell Lung
Source: ClinicalTrials.gov NCT00532155 ↗
Enrolled (actual)
913
Serious AEs
41.7%
Results posted
Jan 2013
Primary outcomePrimary: Overall Survival (OS) — 10.41; 10.05 months — p=0.8985
Summary
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).
The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
10.41; 10.05 | 0.8985 |
| SECONDARY Progression Free Survival (PFS) |
4.11; 5.19 | 0.0035 sig |
| SECONDARY Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria |
0.2; 0.2; 8.6; 23.0; 8.9; 38.6 | — |
| SECONDARY Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS) |
29.52; 31.54; 29.50; 30.54; 27.67; 29.61 | — |
| SECONDARY Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI) |
26.17; 28.24; 26.23; 27.05; 24.52; 26.19 | — |
Eligibility Criteria
Inclusion Criteria
- Histological/cytological proven locally advanced or metastatic non-small cell lung cancer
- Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Adequate renal, liver and bone marrow functions
Exclusion Criteria
- Squamous histology/cytology
- Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
- Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow
- Prior docetaxel treatment
- Uncontrolled hypertension
The above information was not intended to contain all considerations relevant to participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00532155). 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.