Clinical trial of metformin and valproic acid combination in lung cancer
- Conditions
- Health Condition 1: C342- Malignant neoplasm of middle lobe,bronchus or lung
- Registration Number
- CTRI/2022/08/045109
- Lead Sponsor
- JIPMER Intramural fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 countââ?°Â¥ 3 Ã?â?? 109 /L with neutrophils ââ?°Â¥ 1.5 Ã?â?? 109/L , platelet count ââ?°Â¥ 1 lakh/mL and Hb ââ?°Â¥ 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method