Phase 3
Completed N=1,125
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
Source: ClinicalTrials.gov NCT00148798 ↗Enrolled (actual)
1,125
Serious AEs
51.3%
Results posted
Oct 2011
Primary outcomePrimary: Overall Survival Time (OS) — 11.3; 10.1 months — p=0.0441
Summary
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Time (OS) |
11.3; 10.1 | 0.0441 sig |
| SECONDARY Progression-free Survival Time |
4.8; 4.8 | 0.3869 |
| SECONDARY Best Overall Response Rate |
36.4; 29.2 | 0.0101 sig |
| SECONDARY Disease Control Rate |
72.5; 71.5 | 0.6801 |
| SECONDARY Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status |
45.72; 46.36; 48.33; 51.55; 54.71; 52.92 | — |
| SECONDARY Quality of Life Assessment (EORTC QLQ-C30) Social Functioning |
66.17; 64.73; 58.05; 67.13; 67.36; 66.47 | — |
| SECONDARY A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations |
223.1; 51.5 | — |
| SECONDARY Safety - Number of Patients Experiencing Any Adverse Event |
545; 549 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
- Immunohistochemical evidence of EGFR expression on tumor tissue
- Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area
Exclusion Criteria
- Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
- Previous chemotherapy for NSCLC
- Documented or symptomatic brain metastasis
- Superior vena cava syndrome contra-indicating hydration
- Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Data sourced from ClinicalTrials.gov (NCT00148798). 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.