Immunotherapy + Radiation for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 9

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects of ipilimumab and nivolumab in combination with radiation therapy, and to see how well they work in treating patients with stage II-III non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Ipilimumab and nivolumab may also help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Giving ipilimumab and nivolumab in combination with radiation therapy may work better in treating patients with stage II-III non-small cell lung cancer compared to standard chemotherapy in combination with radiation therapy.

Research Team

Anne S Tsao

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with stage II-III non-small cell lung cancer that can't be removed by surgery or patients who refuse surgery. They must have a good performance status, meaning they're fairly active and able to care for themselves. People with certain stable autoimmune conditions or controlled diabetes may join. However, those with recent other cancers, severe allergies to similar drugs, untreated infections like TB or hepatitis, HIV, or on immunosuppressive therapy cannot participate.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

My cancer has an EGFR mutation or ALK rearrangement.

You have enough white blood cells called neutrophils.

Exclusion Criteria

You have had strong allergic reactions to certain types of medications made from antibodies or fusion proteins.

Pregnant women

I am HIV positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Concurrent Therapy

Patients receive nivolumab and ipilimumab intravenously, and undergo radiation therapy 5 days a week for 6-7 weeks

6-7 weeks

5 visits per week (in-person)

Maintenance Therapy

Patients receive nivolumab intravenously every 28 days for up to 8 cycles

up to 8 months

1 visit per month (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab
• Radiation Therapy

Trial Overview The trial tests the combination of two immune system-boosting drugs (Ipilimumab and Nivolumab) with radiation therapy against lung cancer. The goal is to see if this combo helps the body's own defense system fight cancer better and makes tumor cells more sensitive to radiation compared to standard chemotherapy plus radiation.

Participant Groups

Group I: Treatment (nivolumab, ipilimumab, radiation therapy) Experimental Treatment 3 Interventions

CONCURRENT THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 30 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 8 cycles, and treatment with ipilimumab repeats every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 1 day of starting nivolumab and ipilimumab, patients also undergo radiation therapy 5 days a week (Monday-Friday) over 6-7 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+