Chemotherapy + Radiation +/− Metformin for Lung Cancer

Recruiting at 223 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NRG Oncology

Must not be taking: Metformin, Insulin

Disqualifiers: Diabetes, Metastasis, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Concurrent chemoradiotherapy phase followed by consolidation therapy

170 Participants Needed

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.

Timeline

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

Treatment Details

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.

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 United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+