Trials / Completed
CompletedNCT03353675
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)
A Phase II Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Transgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TG4010 | 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks |
| DRUG | Chemotherapy | Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance |
| DRUG | Nivolumab | 360 mg IV administration every 3 weeks |
Timeline
- Start date
- 2018-01-05
- Primary completion
- 2019-11-20
- Completion
- 2021-02-17
- First posted
- 2017-11-27
- Last updated
- 2022-01-11
- Results posted
- 2022-01-11
Locations
9 sites across 4 countries: United States, Belgium, France, Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03353675. Inclusion in this directory is not an endorsement.