Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: standard dose bevacizumab: Patients will receive bevacizumab 15 mg/kg and carboplatin AUC 6, in combination with either paclitaxel 200 mg/m2or pemetrexed 500 mg/m2(based on physician ch
cycles will be administered once every 3 weeks for 4 cycles, followed by bevacizumab 15 mg/kg maintenance (in patients with non-progressive disease) every 3 weeks until disease progression or intolera
cycles will be administered once every 3 weeks for 4 cycles, followed by bevacizumab 5 mg/kg maintenance (in patients with non-progressive disease) every 3 weeks until disease progression or intolerab
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have non-squamous NSCLC warranting palliative chemotherapy in the first line setting. Patients who have received one or two cycles of palliative systemic chemotherapy, while awaiting the results of molecular driver mutation testing will be considered eligible for this study. 2. Aged = 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 4. Normal organ and marrow functions as per the institute protocols 5. Patients with human immunodeficiency virus (HIV)infection are potentially eligible, as long as they have a CD4 count > 200 cells/mm3, are on concurrent highly active antiretroviral therapy (HAART), and have the absence of active AIDS defining conditions 6. Unable to receive, have a contraindication to, or there is no indication for immune checkpoint inhibitors or molecularly targeted therapies in the first line setting 7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments 8. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1. Subjects who are receiving any other investigational agents 2. Current use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e. Steroid use for avoidance or treatment of emesis. 3. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent, including a. Clinically significant (i.e., active)cardiovascular disease, cerebrovascular accident/stroke ( b. Patients with severe renal and liver dysfunction Child Pugh B or C 4. Prior organ transplantation including allogeneic stem-cell transplantation 5. Known severe hypersensitivity to bevacizumab or any of the excipients of this product 6. Patients with Mutation positive Lung cancer receiving at least one line of chemotherapy with progression disease. 7.. Pregnant and lactating women are excluded from this study. 8. History of: a.Recent (within preceding 3 months) stroke or cerebrovascular accident b.Documented hemorrhagic diathesis or coagulopathy c.Active untreated arterial thromboembolic event d.Significant, i.e., grade 2 or higher hemoptysis ( > ½ teaspoon bright red blood per event) attributable to the lung primary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the overall survival between low dose bevacizumab versus low dose bevacizumab added to platinum-based combination chemotherapy in the first line setting in non-squamous NSCLCTimepoint: at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| a.To compare investigation-assessed progression-free survival between 2 arms b.To compare the quality of life between 2 arms c.To compare the adverse event rates between 2 arms d.To compare the investigator-assessed response rate between the 2 armsTimepoint: 1. At disease progression 2. QOL forms will be collected at baseline at 2 months at 4 months & at 6 months. 3.At every visit 4. Every 2 months | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Centre
Outcome results
None listed