Health Condition 1: C342- Malignant neoplasm of middle lobe,bronchus or lung
Conditions
Interventions
Intervention1: T.Metformin 1000 mg BD
T.Valproate 20 mg/kg/day
for 9 weeks in addition to chemotherapy: Metformin 1000 mg BD and Valprate 20 mg/kg/day adjusted to a target plasma concentration of 50-1
Sponsors
JIPMER Intramural fund
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age = 18 years 2.Histologically or cytologically confirmed NSCLC, Stage III B or IV planned for palliative intent treatment with pemetrexed + carboplatin. Patients will be enrolled at baseline or within 3 weeks of cy-cle 1 of chemotherapy. 3.ECOG performance status of = 2. 4.WBC count= 3 × 109 /L with neutrophils = 1.5 × 109/L , platelet count = 1 lakh/mL and Hb = 9 gm/dL 5.Total Bilirubin = 1.5 times the upper limit of nor-mal range 6. AST & ALT = 5 times the upper limit of normal range 7. Patients with measurable disease by RECIST 1.1 criteria
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or allergy to Metformin or valproic acid. 2. Known EGFR or ALK or ROS1 or BRAF or MET or RET mutation in which targeted therapy like erlotinib,gefitinib would be the standard of care. 3. Patient with history of lactic acidosis, chronic kidney disease or baseline creatinine = 1.2 mg/dl 4. Patient who is already on metformin at the time of study entry. 5.Women who are pregnant or breast feeding. 6.History of previous chemotherapy for NSCLC 7.Participation in another clinical trial or treatment with any investigational agent 3 months prior to inclusion in this study. 8. Documented or symptomatic brain metastasis 9. Known diabetes or baseline fasting glucose > 126 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate by using RECIST 1.1 criteriaTimepoint: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival and Overall SurvivalTimepoint: 6 months;ToxicityTimepoint: 9 weeks;Quality of LifeTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Vignesh A
JIPMER Puducherry
Outcome results
None listed