Health Condition 1: C34- Malignant neoplasm of bronchus andlung
Conditions
Interventions
Intervention1: Metformin: Metformin, orally with food, administered continuously, beginning with chemotherapy. Metformin treatment will follow a dose escalation scheme, starting with a dose of 500 mg
Sponsors
Department of Medical Oncology
Eligibility
Inclusion criteria
Inclusion criteria: • Pathological diagnosis of NSCLC (adenocarcinoma/not otherwise specified) • Stage IIIB/C (not amenable for definitive chemoradiation) and IV disease • ECOG PS 0-1 • Serum creatinine less than/equal to 1.5 mg/dl or creatinine clearance greater than/equal to 60 ml/min. • Serum bilirubin • Haemoglobin > 10 mg%, Platelet count > 1 lakh/mm3, ANC > 1500/mm3 • Able to understand the PIS (patient information sheet) and give informed consent
Exclusion criteria
Exclusion criteria: • EGFR/ALK mutated histologically proven NSCLC • Not able to take oral medicines • Type 1 or 2 diabetes • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin • History of any other malignancy in past or synchronous malignancy • Pregnant and lactating mothers • Symptomatic brain metastasis (treated, asymptomatic brain metastasis would be allowed) • HIV positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if addition of metformin with pemetrexed carboplatin in patients with previously untreated advanced or metastatic NSCLC can increase 6 month PFS rate from 50% to 65%Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine frequency of STK11 gene mutation in our population and to co-relate it with clinical behaviour and prognosisTimepoint: end of study;To determine whether STK11 gene status in tumours is a significant determinant of response when metformin is added to the therapyTimepoint: End of study;To evaluate safety of addition of metformin with pemetrexed carboplatinTimepoint: Day 1 of each of 4 cycles of chemotherapy and 6 months | — |
Countries
India
Contacts
Public ContactDr Prabhat Singh Malik
Department of Medical Oncology, All India Institute of Medical Sciences, New delhi
Outcome results
None listed