Health Condition 1: null- The study subjects would consist of patients with advanced EGFR mutation-positive NSCLC who have received Gefitinib as first line treatment in palliative setting
Conditions
Interventions
Intervention1: Pemetrexed and Carboplatin and Gefitinib: The recommended dose of pemetrexed is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex aged 18 years or older 2.Histologically or cytologically proven diagnosis of NSCLC other than predominantly squamous cell histology with an activating EGFR tyrosine kinase (TK) mutation 3.Performance Status 0-1 4.Progressive disease on first-line TKI 5.T790M mutation negative status. 6.Written informed consent prior to study treatment. 7.All patients should have achieved either a stable disease or objective response to the first line TKI and later develop disease progression. 8.Patients with Brain metastasis
Exclusion criteria
Exclusion criteria: 1.Prior chemotherapy or other systemic anti-cancer treatment (excluding Gefitinib). 2.Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease. 3.Neutrophils 4.Serum bilirubin >1.5 x the upper limit of normal (ULN). 5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN in the absence of liver metastases, or >5 x ULN in the presence of liver metastases. 6.Creatinine clearance 7.Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) as judged by the investigator. 8.Other co-existing malignancies or malignancies diagnosed within the last 5 years (except non-melanoma skin cancer or in-situ cervical cancer). 9.Life expectancy of less than 3 months 10.Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS)Timepoint: At progression & at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Overall survival (OS) defined as the time from the date of randomisation until death due to any cause. 2.Objective Response Rate (ORR) defined as per RECIST criteria 3.Disease Control Rate (DCR) in each of the treatment arms 4.Quality of Life - This will be measured by EORTC QOL Q-30 and LC13 5.Adverse Events and Toxicities will be recorded at each visit as per CTCAE 4.03 criteria Timepoint: 1. OS: at end of study 2. ORR: At the time of progression 3. DCR: At the time of progression 4. QOL: at randomization and subsequently every 2to 3 months 5. Toxicities: At every visit | — |
Countries
India
Contacts
Public ContactDr Amit Joshi
Tata Memorial Hospital
Outcome results
None listed