Phase 3
Completed N=924
ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
Source: ClinicalTrials.gov NCT00404924 ↗Enrolled (actual)
924
Serious AEs
24.2%
Results posted
Mar 2012
Primary outcomePrimary: Overall Survival (OS) — 8.5; 7.8 Months
Summary
This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
8.5; 7.8 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.9; 1.8 | — |
| SECONDARY Objective Response Rate (ORR) |
16; 2 | — |
| SECONDARY Disease Control Rate (DCR) |
189; 48 | — |
| SECONDARY Duration of Response (DoR) |
23.9; 24.3 | — |
| SECONDARY Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF) |
6.1; 7.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Non-small cell lung cancer for which the standard cancer treatments of surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate treatments for you.
Exclusion Criteria
- Patients who have had standard cancer treatments of surgery, chemotherapy or other systemic anti-cancer therapy within 4 weeks before start of study therapy.
- Three or more prior chemotherapy regimens.
- Significant cardiovascular events.
Data sourced from ClinicalTrials.gov (NCT00404924). 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.