Phase 3
Completed N=1,240
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
Source: ClinicalTrials.gov NCT00364351 ↗Enrolled (actual)
1,240
Serious AEs
28.5%
Results posted
May 2011
Primary outcomePrimary: Progression-Free Survival (PFS) — 11.3; 8.9 Weeks
Summary
To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
11.3; 8.9 | — |
| SECONDARY Overall Survival (OS) |
6.9; 7.8 | — |
| SECONDARY Objective Response Rate (ORR) |
75; 74 | — |
| SECONDARY Disease Control Rate (DCR) |
254; 242 | — |
| SECONDARY Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain |
11.1; 9.9 | — |
| SECONDARY Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea |
12; 12.4 | — |
| SECONDARY Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough |
15.6; 14.1 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed locally advanced or metastatic NSCLC
- Failure of at least one but not more than two prior chemotherapy regimens
Exclusion Criteria
- Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar)
- Chemotherapy or other type of anti cancer therapy within 4 weeks of study start
Data sourced from ClinicalTrials.gov (NCT00364351). 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.