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Alkylating agent

Chemotherapy + Radiation +/− Metformin for Lung Cancer

Phase 2

Waitlist Available

Led By Theodoros Tsakiridis

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified

Patients must have unresectable disease, be medically inoperable, or unwilling to undergo surgical management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to last follow-up. maximum follow-up at time of analysis was 47.2 months.

Awards & highlights

Study Summary

This trial is comparing two ways of treating patients with stage III non-small cell lung cancer with chemotherapy and radiation. One group of patients will also receive metformin hydrochloride, a drug that may help to keep the tumors from coming back. It is not yet known if this combination of treatments is more effective than just chemotherapy and radiation alone.

Who is the study for?

This trial is for adults with stage III non-small cell lung cancer who have good organ function and no history of allergic reactions to certain chemotherapy drugs. They must not have had previous systemic chemotherapy or radiotherapy overlapping the study area, no distant metastasis, and cannot be using metformin or other diabetes medications.Check my eligibility

What is being tested?

The trial is testing if adding metformin hydrochloride to standard chemotherapy (carboplatin and paclitaxel) and radiation therapy improves outcomes in treating stage III non-small cell lung cancer. It's a phase II study where patients are randomly assigned to receive either the standard treatment alone or with metformin.See study design

What are the potential side effects?

Possible side effects include those from chemotherapy like nausea, hair loss, fatigue, risk of infection; from radiation such as skin irritation, difficulty swallowing; and from metformin including stomach upset, diarrhea. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed and is at stage IIIA or IIIB.

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My condition cannot be treated with surgery.

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I had pneumonia due to a blockage but no longer need IV antibiotics.

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I can carry out all my usual activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. maximum follow-up at time of analysis was 47.2 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 47.2 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. maximum follow-up at time of analysis was 47.2 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Alive Without Progression (Progression-free Survival)

Secondary outcome measures

Percentage of Participants Alive (Overall Survival)

Percentage of Participants With Distant Metastases

Percentage of Participants With Local-regional Progression

+1 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Metformin + ChemoradiationExperimental Treatment4 Interventions

Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Group II: ChemoradiationActive Control3 Interventions

60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Carboplatin

2014

Completed Phase 3

~6670

Metformin

2006

Completed Phase 4

~2430

Paclitaxel

2011

Completed Phase 4

~5380

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,682 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,983 Total Patients Enrolled

Theodoros TsakiridisPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial taking place in numerous locations within the state?

"In total, this trial is running at 103 sites with locations including Zablocki Veterans Administration Medical Center in Milwaukee, Wisconsin, Dekalb Medical Center in Decatur, Georgia, and West Michigan Cancer Center in Kalamazoo, Michigan."

Answered by AI

How many study participants are needed to complete this research?

"No, this particular study is no longer recruiting patients. The trial was initially posted on 8/1/2014 and was last updated on 5/23/2022. However, if you are interested in other studies, there are presently 4428 trials actively recruiting patients with bronchioloalveolar carcinoma and 1402 studies for Metformin admitting patients."

Answered by AI

Are there any volunteers still needed for this experiment?

"Unfortunately, this particular trial is no longer recruiting patients. The first posting was on August 1st, 2014 and the most recent update was on May 23rd, 2022. However, there are 4,428 other trials related to bronchioloalveolar carcinoma and 1,402 that involve Metformin currently looking for participants."

Answered by AI

Is there a increased chance of negative side effects from Metformin?

"Metformin's safety is supported by some clinical data, but not enough to give it a 3."

Answered by AI

What is Metformin's standard application in the medical field?

"Metformin can be used as a palliative therapy for patients with malignant peritoneal neoplasm and advanced endometrial cancer."

Answered by AI

What are the most recent findings from other research teams regarding Metformin's effects?

"Metformin was first studied in 1997. Since the initial research project, there have been a total of 2732 completed clinical trials. As of now, 1402 studies are ongoing with several located in Milwaukee, Wisconsin."

Answered by AI

Recent research and studies

JAMA OncologyJournal

Addition of Metformin to Concurrent Chemoradiation in Patients with Locally Advanced Non–small Cell Lung Cancer

Skinner, Heath, Chen Hu, Theodoros Tsakiridis, Rafael Santana-Davila, Bo Lu, Jeremy J. Erasmus, Anthony J. Doemer, et al.. 2021. “Addition of Metformin to Concurrent Chemoradiation in Patients with Locally Advanced Non–small Cell Lung Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2021.2318.

clinicaltrials.govStudy

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer

2014. "Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02186847.

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