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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
Must not have
Patients with mixed small cell and non-small cell histologies
Patients with distant metastasis
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
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung cancer is a mix of small cell and non-small cell types.
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My cancer has spread to distant parts of my body.
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I have had radiotherapy in the same area as my current cancer.
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I am allergic to paclitaxel, other taxanes, or carboplatin.
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I have lost 10% or more of my weight in the last month.
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I have a history of chronic kidney disease or lactic acidosis.
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I have received chemotherapy for my current cancer.
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I am currently taking medication for diabetes.

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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Alive Without Progression (Progression-free Survival)
Secondary study objectives
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
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~6120
Metformin
2006
Completed Phase 4
~2430
Paclitaxel
2011
Completed Phase 4
~5450

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
238 Previous Clinical Trials
102,921 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,000 Total Patients Enrolled
Theodoros TsakiridisPrincipal InvestigatorNRG Oncology
~15 spots leftby Dec 2025
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