Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
Summary
This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune responses in patients with non-small cell lung cancer.
Timeline
- Start
- 2016-06-17
- Primary completion
- 2022-11-19
- Completion
- 2022-12-28
Outcome
Missed primary endpoint
registry analysis (other test); Arm I (Pembrolizumab) vs Arm II (Pembrolizumab, Paclitaxel, Carboplatin); p = 0.366; Log Rank NCT02581943 ↗
registry analysis (other test); Arm I (Pembrolizumab) vs Arm II (Pembrolizumab, Paclitaxel, Carboplatin); p = 0.63; Log Rank NCT02581943 ↗
registry analysis (other test); Arm I (Pembrolizumab) vs Arm II (Pembrolizumab, Paclitaxel, Carboplatin); p = 0.692; Log Rank NCT02581943 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |