drugset / Trial / NCT04287894
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment
Non-randomizedSingle-groupOpen-labelTreatment
Summary
A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy in the treatment of locally advanced NSCLC.
Timeline
- Start
- 2018-12-28
- Primary completion
- 2024-11-04
- Completion
- 2024-11-04
Outcome
Outcome not reported
Stopped: “Based on initially defined safety rules not continued with expansion phase of study (too much toxicity with neo-adjuvant immunotherapy)”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | — |
| Background | Cisplatin | Other / unclassified | 6 mg/m2 | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | — |