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)

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Transgene
Study ID
NCT03353675
Phase
PHASE2
Status
Completed

Conditions

  • Non Small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TG4010 — BIOLOGICAL
    1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks
  • Chemotherapy — DRUG
    Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance
  • Nivolumab — DRUG
    360 mg IV administration every 3 weeks

Study Details

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.

Key Dates

Start date
Jan 5, 2018
Status verified
Dec 2021
Primary completion
Nov 20, 2019
Completion
Feb 17, 2021

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TG4010/Chemotherapy/Nivolumab

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 15 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
CharlotteCharlotteNorth Carolina28204-
NashvilleNashvilleTennessee37203-

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By research site
Charlotte· Charlotte, NCNashville· Nashville, TN

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