CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 17 enrolled
Drug / intervention
Metformin Hydrochloride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03048500
NCT03048500Phase 2Unknown

Parallel Proof of Concept Phase 2 Study of Nivolumab and Metformin Combination Treatment in Advanced Non-small Cell Lung Cancer With and Without Prior Treatment With PD-1/PD-L1 Inhibitors

Northwestern University·interventional·Posted Feb 9, 2017·Updated Oct 14, 2020

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Metformin Hydrochloride, and 1 other intervention for Recurrent Non-Small Cell Lung Carcinoma and 4 related conditions. Targeting 17 participants across 2 sites.

Detailed Summary

The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We will also be looking at the safety of the combination. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by the US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is being used to treat cancer. This use is not approved by the FDA; therefore, in this study, it is considered experimental. Experimental means the U.S. FDA has not approved the drug for use in your type of cancer. Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. It is believed that metformin has immune modifying properties, meaning it can boost your immune system. As a result, it may help certain cancer treatments, known as immunotherapy, to work better.

Study Details

Timeline

Phase 2UnknownOverdue
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartJul 12, 2017
Primary CompletionSep 19, 2019
Study CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.4 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Metformin Hydrochloridedrug

Given PO

Nivolumabbiological

Given IV