drugset / Trial / NCT04105270
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, active-controlled, parallel-group, double-blind Phase II trial, of oral restorative microbiota therapy (RMT) or placebo combined with intravenous (IV) durvalumab (MEDI4736) plus chemotherapy in patients with treatment naïve advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC)
Timeline
- Start
- 2022-11-30
- Primary completion
- 2028-01
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Restorative Microbiota Therapy | Unknown | — | Oral |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Background | Pemetrexed | Small molecule | — | — |