170 Participants Needed

Chemotherapy + Radiation +/βˆ’ Metformin for Lung Cancer

Recruiting at 223 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.

Who Is on the Research Team?

TT

Theodoros Tsakiridis

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My recent blood test shows my bone marrow is working well.
It has been over 3 weeks since my chest surgery.
Patients must have a disease that can be measured.
See 13 more

Exclusion Criteria

Severe, active co-morbidity, defined as follows
I am allergic to paclitaxel, other taxanes, or carboplatin.
My lung cancer is a mix of small cell and non-small cell types.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemoradiotherapy with or without metformin hydrochloride

Concurrent chemoradiotherapy phase followed by consolidation therapy
Regular visits for chemotherapy and radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks initially, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter
Multiple follow-up visits over several years

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Metformin Hydrochloride
  • Paclitaxel
  • Radiation Therapy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Metformin + ChemoradiationExperimental Treatment4 Interventions
Group II: ChemoradiationActive Control3 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials
242
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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