Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squa… (NCT02019979) | Clinical Trial Compass
TerminatedPhase 2
Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)
Stopped: PI left the institution
United States14 participantsStarted 2013-12
Plain-language summary
Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of cellular energy levels and a key enzyme limiting cellular growth during times of cellular stress. Once activated, this enzyme restricts anabolic processes such as protein, cholesterol and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for unregulated growth. MTOR is upregulated in a variety of tumors, including NSCLC providing rationale to take advantage of this pathway with metformin.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to provide written consent and is amenable to compliance with protocol schedules and testing
✓. Patient is \> 18 years of age
✓. Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIB or IV non-squamous non-small cell lung cancer
✓. No prior, palliative chemotherapy for stage IV lung cancer Patients who have received adjuvant chemotherapy post surgery for curative intent more than 12 months prior to development of stage IV disease are allowed.
✓. Measurable disease as RECIST criteria 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
✓. CT Scan of the chest/abdomen/pelvis or PET Scan within 30 days of study entry
✓. An MRI of the brain or Head CT Scan with contrast within 30 days of study entry if clinically indicated
✓. ECOG Performance Status 0-2.
Exclusion criteria
✕. The patient has a diagnosis of squamous cell carcinoma. Adenosquamous (mixed) histologies are allowed
What they're measuring
1
Progress Free Survival
Timeframe: Time after day 1 cycle 1 to first disease progression for up to 20 months
✕. The patient has a history of type I or type II diabetes
✕. Weight of less than 80% of (IBW) ideal body weight
✕. Creatinine clearance less than 45 l/min as calculated by the Cockcroft-Gault equation
✕. Known EGFR or ALK mutation in which targeted therapy with erlotinib or crizotinib would be the standard of care. Those patients whose tissue is not tested or have insufficient material are eligible
✕. The patient is currently taking or has previously taken metformin in the past 6 months
✕. The patient has received previous chemotherapy for NSCLC except in instances of adjuvant therapy post surgical resection more than 12 months prior to enrollment
✕. The patient has undergone major surgery within four weeks prior to randomization.