drugset / Trial / NCT03353675
A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with \< 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.
Timeline
- Start
- 2018-01-05
- Primary completion
- 2019-11-20
- Completion
- 2021-02-17
Outcome
Missed primary endpoint
release “the primary endpoint ( overall response rate) of the Phase 2 trial evaluating TG4010 in combination with chemotherapy and Opdivo® (nivolumab) was not reached.” transgene.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | TG4010 | Vaccine | 1e+08 unknown | Subcutaneous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Pemetrexed | Small molecule | — | — |