Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Gefitinib|Carboplatin|Paclitaxel
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/Efficacy Primary Outcomes: To compare gefitinib with carboplatin/paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival. Secondary Outcomes: To compare Iressa v carboplatin/paclitaxel in terms of overall survival; To compare Iressa carboplatin/paclitaxel in terms of objective tumour response rate; To compare the safety and tolerability profile of Iressa v carboplatin/paclitaxel. | — |
Outcome results
None listed