Health Condition 1: null- Lung Cancer patients
Conditions
Interventions
Intervention1: Gefitinib: Tab Gefitinib 250mg administered orally once daily. One tablet of gefitinib should be taken everyday in about the same time with or without food. If the patient forgets to
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: •Provision of informed consent •Male or female aged >= 18 Years •Histologically or cytologically confirmed non-small cell lung carcinoma with adenocarcinoma histology (including bronchoalveolar). Note: adeno-sqaumous histology is not allowed. Sputum cytology alone is not allowed. Cytological specimens obtained by brushing, washing, or needle aspiration of a defined lesion are acceptable. •Locally advanced stage IIIB not amenable to local therapy or stage IV (metastatic) disease. •Never smokers or light ex-smokers (defined as having ceased smoking at least 1 years before Day 1 of study treatment and having smoked 10 pack-years or fewer) •No prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors) or immunological therapy. Previous adjuvant chemotherapy is permitted if treatment was not platinum-based and was completed more than 6 months before day 1. Palliative radiotherapy to a metastatic site is permitted, but palliative wide field radiotherapy to the lung must be completed at least 4 weeks before day 1 with no persistence of any radiotherapy-related toxicity. •Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated •WHO performance status (PS) of 0 to 2 •Patients must be willing to complete the EORTC QOL .
Exclusion criteria
Exclusion criteria: 1. Known Severe hypersensitivity to Gefitinib 2. Known Severe hypersensitivity to platinum & pemetrexed 3. Newly Diagnosed CNS mets 4. History of presence of any other malignancy with the exception of basal cell carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to compare gefitinib with platinum / pemetrexed doublet chemotherapy given as first line treatment in terms of progression free survival in selected EGFR mutation-positive NSCLC patients.Timepoint: Around a year | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Overall survival â?¢Objective tumour response rate according to RECIST criteria â?¢The safety & tolerability profile of Gefitinib at a 250mg daily dose relative to that of Platinum / Pemetrexed chemotherapy â?¢Quality of life as measured by the total score and Trial Outcome Index (TOI) of the EORTC- QOL. Timepoint: 1. OS in 2 years 2. Tumor response at 2 months 3. Safety through the study 4. QOL every 2 months | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed