SBRT +/− Nivolumab for Lung Cancer

Palo Alto (17 mi)

Overseen byJoe Y Chang, MD,MS,PHD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and nivolumab may work better at treating non-small cell lung cancer.

Eligibility Criteria

This trial is for patients with stage I-IIA or recurrent non-small cell lung cancer without distant metastases. Participants must have completed any prior treatments at least 12 weeks before, tumors should be ≤7 cm (N0M0), and they should use effective birth control. They need to meet certain blood count criteria, have a performance status score of 0-2, and sign consent forms.

Inclusion Criteria

My lung cancer came back in the same place after surgery or chemo/radiotherapy.

I have more than one primary lung cancer.

I can take care of myself and am up and about more than 50% of my waking hours.

My lung cancer diagnosis was confirmed through a biopsy or cytology.

I have only one cancer spot in my lung and no other cancer spots elsewhere.

Exclusion Criteria

My tumor is not larger than 7 cm and does not involve critical body parts.

I am not planning to receive other treatments while on this trial, except if my disease worsens.

I do not have HIV, hepatitis B, or hepatitis C.

I have not had any other cancers or spread of cancer in the last 3 years.

I have not had treatments targeting immune system pathways.

I have not been treated with PD1 or CTLA4 immunotherapy.

My treatment plan does not meet the required safety standards for targeted radiation.

I do not have any conditions that prevent me from receiving radiotherapy.

I do not have an active autoimmune disease.

Treatment Details

The trial is testing the effectiveness of stereotactic body radiation therapy (SBRT) alone versus SBRT combined with Nivolumab, an immunotherapy drug. SBRT targets tumors precisely to minimize damage to healthy tissue while Nivolumab aims to boost the immune system's response against cancer cells.

2Treatment groups

Experimental Treatment

Group I: Arm II (stereotactic body radiation therapy, nivolumab)Experimental Treatment2 Interventions

Patients undergo stereotactic body radiation therapy over 1-2 weeks. Beginning within 36 hours before or after the first fraction of stereotactic body radiation therapy, patients also receive nivolumab IV over 30 minutes on day 1. Cycles with nivolumab repeat every 4 weeks for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (stereotactic body radiation therapy)Experimental Treatment1 Intervention

Patients undergo stereotactic body radiation therapy over 1-2 weeks.

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

🇺🇸 Approved in United States as Opdivo for: