CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
TG4010 +2 morebiological
Likely dose
Nivolumab 360 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03353675
NCT03353675Phase 2Completed
CompareCT.gov

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)

Transgene·interventional·Posted Nov 27, 2017·Updated Jan 11, 2022

In Brief

A Phase 2 clinical trial evaluating TG4010, Chemotherapy, and 1 other intervention for Non Small Cell Lung Cancer Metastatic. Completed, enrolled 44 participants across 9 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer Metastatic
CountriesBelgium, France, Hungary, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 27, 2017
Enrollment StartJan 5, 2018
Primary CompletionNov 20, 2019
Study CompletionFeb 17, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.6 years ago

Interventions

TG4010biological

1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks

Chemotherapydrug

Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance

Nivolumabdrug

360 mg IV administration every 3 weeks