MedTrace Logo

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)

NCT02019979 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-05-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Non-small Cell Lung Cancer Stage IIIB/IV
  • Non-small Cell Lung Cancer Metastatic
  • Nonsquamous Nonsmall Cell Neoplasm of Lung

Interventions

DRUG

metformin

Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

BEHAVIORAL

carbohydrate restricted diet

addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Sponsors & Collaborators

  • St. Luke's-Roosevelt Hospital Center

    collaborator OTHER

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Benjamin Levy, M.D. · Beth Israel Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019979 on ClinicalTrials.gov