Immunotherapy + SBRT for Advanced Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMichael K. Farris

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throughout the body) in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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. Giving immunotherapy with stereotactic body radiation therapy may work better than immunotherapy alone in treating patients with non-small cell lung cancer.

Eligibility Criteria

This trial is for adults with stage IV non-small cell lung cancer that has spread and can be targeted by radiation. They must have had at least 4 cycles of systemic therapy without disease progression, be within 180 days from their first dose of this therapy, and have a performance status of 0-2. Pregnant women or those treated for other cancers (with some exceptions) in the last three years are excluded.

Inclusion Criteria

I had early-stage lung cancer, treated it, but now have cancer in distant areas and have completed 4 cycles of treatment for this recurrence.

I am 18 years old or older.

My remaining cancer can be targeted with radiation according to my radiation oncologist.

+5 more

Exclusion Criteria

It has been over 6 months since I started my standard cancer treatment.

My cancer does not have major EGFR mutations or ROS1/ALK rearrangements.

I haven't been treated for cancer in the last 3 years, except for certain low-risk or early-stage cancers.

+1 more

Participant Groups

The study compares two approaches: one group receives immunotherapy with pembrolizumab plus stereotactic body radiation therapy (SBRT), while the other gets only pembrolizumab. SBRT delivers precise high-dose radiation to tumors over fewer sessions, potentially improving outcomes when combined with immunotherapy.

2Treatment groups

Experimental Treatment

Group I: Arm 2 Pembrolizumab OnlyExperimental Treatment1 Intervention

Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.

Group II: Arm 1 Stereotactic Body Radiation Therapy/PembrolizumabExperimental Treatment2 Interventions

3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.

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

🇺🇸 Approved in United States as KEYTRUDA for: