Chemotherapy + Radiation +/− Metformin for Lung Cancer

Recruiting at223 trial locations

Overseen by Theodoros Tsakiridis

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Theodoros Tsakiridis

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• Carboplatin (Alkylating agent)
• Metformin Hydrochloride (Anti-diabetic drug)
• Paclitaxel (Mitotic inhibitor)
• Radiation Therapy (Radiation)

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.

Participant Groups

Group I: Metformin + Chemoradiation Experimental Treatment 4 Interventions

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

Group II: Chemoradiation Active Control 3 Interventions

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

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School