Immunotherapy + SBRT for Advanced Lung Cancer

Overseen By Susan Wildman, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Wake Forest University Health Sciences

Must be taking: Chemo-immunotherapy

Disqualifiers: Pregnancy, Recent carcinomas, EGFR mutations, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 year

5 Participants Needed

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.

Research Team

Michael K. Farris

Principal Investigator

Wake Forest University Health Sciences

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab IV every 3-4 weeks for 1 year, with or without stereotactic body radiation therapy (SBRT) consisting of 3-10 treatments

1 year

Every 3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

5 years

1 month after treatment, then every 3 months for 1 year, every 6 months for 2 years, and annually for 2 years

Treatment Details

Interventions

• Pembrolizumab
• Stereotactic Body Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: Arm 2 Pembrolizumab Only Experimental Treatment 1 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/Pembrolizumab Experimental Treatment 2 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:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+