A study to test the efficacy and safety of drugs Pemetrexed and Platinum vs Tablet Gefitinib in Lung Cancer Patients
- Conditions
- Health Condition 1: null- Lung Cancer patients
- Registration Number
- CTRI/2015/08/006113
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 290
•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 .
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method â?¢Overall survival <br/ ><br>â?¢Objective tumour response rate according to RECIST criteria <br/ ><br>â?¢The safety & tolerability profile of Gefitinib at a 250mg daily dose relative to that of Platinum / Pemetrexed chemotherapy <br/ ><br>â?¢Quality of life as measured by the total score and Trial Outcome Index (TOI) of the EORTC- QOL. <br/ ><br>Timepoint: 1. OS in 2 years <br/ ><br>2. Tumor response at 2 months <br/ ><br>3. Safety through the study <br/ ><br>4. QOL every 2 months