Study on Combination Immunotherapy Treatment (N-803 and Pembrolizumab) Versus Usual Treatment for Advanced Non-small Cell Lung Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT05096663
This clinical trial is testing a new combination of immunotherapy drugs, N-803 and pembrolizumab, to see if they work better than the usual treatment for advanced non-small cell lung cancer that has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring whether a combination of two immunotherapy drugs, N-803 and pembrolizumab, can help the immune system fight advanced non-small cell lung cancer (NSCLC) more effectively than the standard treatment. N-803 may activate natural killer cells, which are part of the immune system, to attack cancer cells. Pembrolizumab is a monoclonal antibody that may help the immune system target and destroy cancer cells. The goal is to see if this combination can shrink tumors, stabilize the cancer, or prevent it from coming back.
Description
The main goal of this study is to compare the overall survival of patients receiving the combination of N-803 and pembrolizumab with those receiving the standard treatment for advanced non-small cell lung cancer. The study will also look at how long patients live without the cancer getting worse, the response rates to the treatments, and the duration of response among those who respond to the treatment. Additionally, the study will evaluate the safety and side effects of the treatments.
Participants will be randomly assigned to one of two groups:
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Group A: Will receive the standard treatment, which may include chemotherapy drugs like docetaxel, gemcitabine, pemetrexed, or ramucirumab, given through an IV. Treatment cycles repeat every 21 days as long as the cancer does not progress and side effects are manageable.
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Group B: Will receive pembrolizumab through an IV and N-803 as a subcutaneous injection. Treatment cycles repeat every 21 days for up to 2 years, as long as the cancer does not progress and side effects are manageable. After 2 years, patients will continue to receive N-803 alone.
After completing the study treatment, patients will be followed up for 2 years to monitor their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be assigned to the study by the Southwest Oncology Group (SWOG).
- Must have measurable or non-measurable disease confirmed by CT or MRI scans.
- Must have a recent brain scan to check for cancer spread to the brain.
- Must have controlled and asymptomatic brain or spinal cord metastases if present.
- Must have progressed after the most recent treatment for NSCLC.
- Must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease.
- Must have recovered from any side effects of previous treatments.
- Must be able to safely receive one of the standard treatment options.
- Must meet specific blood count and organ function criteria.
- Must have a performance status score of 0 or 1.
- Must have a history and physical exam within 28 days before starting the study.
- Must be on anti-retroviral therapy and have an undetectable viral load if HIV positive.
- Must agree to participate in specimen collection for future research.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Must not have leptomeningeal disease requiring treatment.
- Must not have severe or unresolved immune-related side effects from previous treatments.
- Must not have a history of organ transplant requiring immunosuppressive drugs.
- Must not have a history of severe lung inflammation or current lung disease.
- Must not have severe heart disease or recent heart attack.
- Must not have had recent arterial blood clots or strokes.
- Must not have uncontrolled infections or other serious medical conditions.
- Must not have cirrhosis or significant liver disease.
- Must not have received certain immune therapies or treatments recently.
- Must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Veterans Administration Medical Center - Birmingham | 35233 | Birmingham | Alabama |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| PCR Oncology | 93420 | Arroyo Grande | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Tower Cancer Research Foundation | 90211 | Beverly Hills | California |
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