Health Condition 1: null- Patients who have EGFR mutation positive Non small Cell lung cancer
Conditions
Interventions
Intervention1: Chemotherapy With Gefitinib: Chemotherapy with Pemetrexed 500mg/m2 + carboplatin AUC 5 x 3weekly for 4 cycles followed by only pemetrexed with Gefitinib 250 mg OD till progression (Arm
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: •Histologically or cytologically confirmed non-small cell lung carcinoma with EGFR mutation positive for exon 19, 21 or 18 •Locally advanced stage IIIB not amenable to local therapy (eg. Pleural effusion) or stage IV (metastatic) disease. •No prior palliative chemotherapy, or palliative 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 EORTC QOL.
Exclusion criteria
Exclusion criteria: •Known severe hypersensitivity to gefitinib or any of the excipients of this product •Known severe hypersensitivity to Platinum, Pemetrexed or any of the excipients of these products •Known severe hypersensitivity to pre-medications required for treatment with Platinum / Pemetrexed doublet chemotherapy •History or presence of any other malignancy with the exception of basal cell carcinoma or cervical cancer in situ •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. •Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline •Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy •As judged by the investigator, any evidence of severe or uncontrolled systemic disease ( e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study. •Adequate organ function, including the following: i)Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) >= 1.5X109/L, Platelets >=100X109/L ii) Hepatic: bilirubin = 60 ml/min. •Pregnancy or breast feeding •Unable to tolerate Platinum / Pemetrexed doublet chemotherapy, as judged by the investigator. •Life expectancy of •Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates •Treatment with a non-approved or investigational drug within 30 days before Day of study treatment •Involvement in the planning and conduct of the study •Previous enrollment or randomization of treatment in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: From date of randomization until the date of disease progression is documented or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Overall Survival 2.Side effects 3.Response rate 4.Quality of lifeTimepoint: 1.Overall survival from randomization until date of death 2.Side effects at each visit 3.Response rate at every six months 4.Quality of life at every planned visit | — |
Countries
India
Contacts
Public ContactKavita Prakash Nawale
Tata Memorial Hospital
Outcome results
None listed