Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Gefitinib 250 mg orally daily with Chemotherapy: gefitinib 250 mg orally daily. Combination chemotherapy will be added, consisting of pemetrexed 500 mg/m2 and carboplatin, area under th
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Histologically or cytologically confirmed NSCLC with EGFR mutation positive for exon 19, 21 or 18 3. Patients planned for palliative intent therapy, i.e., patients in whom radical curative-intent therapy is not possible. 4. ECOG performance status 2 to 4 at baseline. Patients with PS 2 who are felt by the treating physician to be unfit for combination platinum-based chemotherapy will be considered for the trial. All patients with PS 3 and 4 at baseline will be considered eligible for the trial. 5. Patient should be planned for palliative intent therapy in the first line. No prior line of palliative chemotherapy, or palliative biological therapy, including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors or immunological therapy is permitted. Patients may have been started on an oral TKI or chemotherapy for the current diagnosis within the past six weeks on a compassionate basis while awaiting the results of molecular testing. Previous therapy in the definitive setting is permitted. Palliative radiotherapy to a metastatic site is permitted. 6. Adequate organ function, including the following: i) Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) = 1.5 X 109/L, Platelets = 100 X 109/L ii) Hepatic: Serum bilirubin = 2 times the upper limit of normal (x ULN), Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) = 3.5 times the ULN if no demonstrable liver metastases (AST, ALT = 5 XULN is acceptable if liver is involved by tumor). iii) Serum Creatinine = 1.5 times the ULN or Creatinine Clearance = 45 ml/min.
Exclusion criteria
Exclusion criteria: 1.Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), as judged by the investigator. 2. Known severe hypersensitivity to gefitinib or any of the excipients of this product. 3. Known severe hypersensitivity to carboplatin, pemetrexed or any of the excipients of these products. 4. Known severe hypersensitivity to pre-medications required for treatment with platinum and pemetrexed doublet chemotherapy. 5. History or presence of any other malignancy with the exception of basal cell carcinoma or cervical cancer in situ, or curatively treated malignancies that are in remission for over 3 years. Curatively treated NSCLC is an exception; patients with curatively treated NSCLC, who have now recurred and are planned for first line palliative intent therapy may be considered for this trial. 6. 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. 7. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline. 8. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study. 9. Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Timepoint: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1. Progression free survival (PFS) 2. Time to objective second disease progression (PFS2) 3. Objective response rate 4. Clinical benefit rate 5. Depth of response 6. Toxicity 7. Duration of overall response 8. The number of patients who experience a change in symptoms. 9. Time to change in symptoms. 10. QoL (EORTC Q30 and LC13)Timepoint: Progression free survival at progression Time to objective second disease progression at progression evaluation Objective response rate at every 2 months Clinical benefit rate at every 2 months at the time of scan Depth of response at every 2 months Toxicity at every visit Duration of overall response at end of study The number of patients who experience a change in symptoms. at every visit Time to change in symptoms at every visit QoL Baseline and At every planned followup visit;Tertiary Endpoints Tissue and bloodTimepoint: baseline and at all planned visits | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Centre
Outcome results
None listed