Health Condition 1: null- Lung Cancer Patients
Conditions
Interventions
Intervention1: Oral TKI (Arm A): Oral TKI gefitinib 250 mg daily alone
Control Intervention1: Oral TKI with bevacizumab (Arm B): Bevacizumab 7.5 mg/kg intravenously 3-weekly with gefitinib 250 mg oral
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient aged >= 18 years 2. Histologically or cytologically confirmed NSCLC with EGFR mutation positive for exon 19, 21 or 18 3. Disease is not amenable to curative intent therapy; palliative intent therapy is planned. 4. No prior palliative chemotherapy, or palliative biological (including targeted therapies such as EGFR and vascular epidermal growth factor inhibitors) or immunological therapy.Previous adjuvant chemotherapy is permitted if treatment was completed at least 6 months before day 1. Palliative radiotherapy to a metastatic site is permitted. 5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) with at least one measurable lesion. 6. ECOG performance status (PS) of 0 to 2 7. Adequate organ function, including the following: i) Adequate bone marrow reserve: absolute neutrophil counts (ANC) >= 1.5X109/L, Platelets >=100X109/L ii) Hepatic: bilirubin iii) Renal: Serum creatinine = 50 ml/min
Exclusion criteria
Exclusion criteria: 1. Known severe hypersensitivity to gefitinib or any of the excipients of this product 2. Known severe hypersensitivity to bevacizumabor any of the excipients of this product. 3. History or presence of any other malignancy within the last 3 years, with the exception of basal cell carcinoma of the skin or cervical cancer in situ 4. 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. 5. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline. 6. Any unresolved chronic toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anticancer therapy. 7. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease). 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 10. Life expectancy of 11. Treatment with an investigational drug within 30 days before day of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if the combination of bevacizumab with oral TKI improves PFS as compared to oral TKI alone.Timepoint: Every 2 months & till disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare overall survival, side effects, response rate and QOL (EORTC Q30 and LC13)Timepoint: Side effects will be evaluated every 2 months in Arm A & Every 3 months in Arm B , ntil disease progression. Overall survival : patients will be evaluated every 2 to 3 months until death. | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed