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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)

NCT03353675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-01-11

Study results available
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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

  • Non Small Cell Lung Cancer Metastatic

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2019-11-20
Completion
2021-02-17
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Hungary

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03353675 on ClinicalTrials.gov