Phase 3
Completed N=1,217
First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
Source: ClinicalTrials.gov NCT00322452 ↗Enrolled (actual)
1,217
Serious AEs
16.9%
Results posted
May 2010
Primary outcomePrimary: Median Progression Free Survival (PFS) in Months — 5.7; 5.8 Months
Summary
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression Free Survival (PFS) in Months |
5.7; 5.8 | — |
| SECONDARY Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010) |
18.8; 17.4 | — |
| SECONDARY Objective Tumour Response Rate According to RECIST |
262; 196 | — |
| SECONDARY Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia |
4; 385 | — |
| SECONDARY Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia |
5; 29 | — |
| SECONDARY Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia |
1; 202 | — |
| SECONDARY Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia |
11; 56 | — |
| SECONDARY Neurotoxicity |
30; 411 | — |
| SECONDARY Rashes/Acnes |
398; 132 | — |
| SECONDARY Diarrhoea |
274; 128 | — |
| SECONDARY Nausea |
74; 260 | — |
| SECONDARY Vomiting |
59; 193 | — |
| SECONDARY Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases |
57; 6 | — |
| SECONDARY Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire |
283; 229 | — |
| SECONDARY Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire |
274; 184 | — |
| SECONDARY Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire |
304; 272 | — |
Eligibility Criteria
Inclusion Criteria
- Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
- Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)
Exclusion Criteria
- Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
- Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
Data sourced from ClinicalTrials.gov (NCT00322452). 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.