Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
Summary
This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight 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. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.
Timeline
- Start
- 2022-03-15
- Primary completion
- 2027-06-30
- Completion
- 2027-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Nogapendekin Alfa | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Comparator | Pemetrexed | Small molecule | — | Intravenous |
| Comparator | Ramucirumab | Monoclonal antibody | — | Intravenous |
| Background | Cobalamin | Small molecule | — | Intramuscular |
| Comparator | Dexamethasone | Small molecule | — | Oral |
| Background | folic acid | Other / unclassified | — | Oral |