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A 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)

NCT03353675

Description:

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 PD-L1 by immunohistochemical (IHC) staining.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A 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)
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: TG4010.24
  • NCT ID: NCT03353675

Conditions

  • NSCLC

Interventions

DrugSynonymsArms
TG4010TG4010/Chemotherapy/Nivolumab
ChemotherapyTG4010/Chemotherapy/Nivolumab
NivolumabTG4010/Chemotherapy/Nivolumab

Purpose

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 PD-L1 by immunohistochemical (IHC) staining.

Trial Arms

NameTypeDescriptionInterventions
TG4010/Chemotherapy/NivolumabExperimental
  • Chemotherapy
  • Nivolumab

Eligibility Criteria

        Principal Inclusion Criteria:

          -  Female or male patients age > 18 years-old

          -  ECOG performance Status 0 or 1 at study entry

          -  Life expectancy of at least 3 months

          -  Histologically confirmed non-squamous NSCLC (adenocarcinoma, large cell carcinoma,
             undifferentiated carcinoma or other)

          -  Stage IIIB-IV cancer or delayed relapse of any stage not amenable to surgery or
             radiotherapy with curative intent.

          -  PD-L1 expression by immunohistochemistry in < 50% of tumor cells

          -  Patients must be chemotherapy-naïve for the advanced stage of the disease. Previous
             neoadjuvant and/or adjuvant chemotherapy is allowed for patients who successfully
             underwent complete radical surgery and if last treatment was administered more than 12
             months prior to the start of the study treatment.

          -  At least one measurable lesion by CT scan based on RECIST 1.1 performed within 28 days
             prior to start of study treatment

          -  Adequate hematological, hepatic, and renal functions

          -  Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
             within 72 hours prior to the start of study drug

          -  WOCBP must agree to follow instructions for method(s) of contraception for the
             duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days
             for a total of 5 months posttreatment completion. Highly effective contraception are
             defined in the protocol.

          -  Men who are sexually active with WOCBP must agree to follow instructions for method(s)
             of contraception for the duration of treatment with study drug (s) plus 5 half-lives
             of study drug (s) plus 90 days for a total of 7 months post-treatment completion

        Principal Exclusion Criteria:

          -  Patients having CNS metastases

          -  Patients with pericardial effusion

          -  Prior exposure to cancer immunotherapy including cancer vaccines, anti-PD-1,
             anti-PD-L1, anti-PD-L2, anti-cytotoxic T-Lymphocyte antigen- 4 antibody or any other
             antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

          -  Patients with EGFR activating mutations or ALK- rearrangements leading to eligibility
             for TKI treatment (tests mandatory)

          -  Prior history of other malignancy except basal cell carcinoma of the skin, cervical
             intra epithelial neoplasia, and other cancer curatively treated with no evidence of
             disease for at least 3 years

          -  Patients with a condition requiring systemic treatment with either corticosteroids or
             other immunosuppressive medications within 14 days of start of study treatment

          -  Patients with an active, known or suspected autoimmune disease

          -  Patient with interstitial lung disease that is symptomatic or may interfere with the
             detection or management of suspected drug-related pulmonary toxicity

          -  Patients with grade ≥ 2 neuropathy

          -  Signs or symptoms of infection within 14 days prior to start of study treatment or
             active infection requiring systemic therapy

          -  Positive serology for HIV or HCV; presence in the serum of the antigens HBs at
             baseline

          -  Patient with any underlying medical condition that the treating physician considers
             might be aggravated by treatment or which is not controlled (e.g., elevated troponin
             or creatinine, uncontrolled diabetes)

          -  History of cardiovascular conditions within 12 months of enrollment

          -  Left ventricular ejection fraction less than the Lower Limit of Normal as assessed by
             echocardiography (or MUGA scan)

          -  Patient with major surgery or radiotherapy within 3 weeks prior to the start of the
             study treatment. However, prior surgery or radiation therapy aimed at local palliation
             or attempted local disease control (except in case of thoracic radiotherapy) is
             permitted but has to be completed 2 weeks before treatment start

          -  Pregnant or nursing (lactating) women

          -  Patients with an organ allograft

          -  Any known allergy to eggs, gentamicin or history of allergy or hypersensitivity to
             study drug components

          -  Participation in a clinical study with an investigational product within 4 weeks prior
             to the start of the study treatments
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:15 months
Safety Issue:
Description:Proportion of patients whose best overall response is CR or PR using RECIST 1.1

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:15 months
Safety Issue:
Description:Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause.
Measure:Disease Control Rate (DCR)
Time Frame:15 months
Safety Issue:
Description:Proportion of patients whose best overall response is either CR, PR, or SD.
Measure:Overall Survival (OS)
Time Frame:27 months
Safety Issue:
Description:Time from the date of first study treatment administration to the date of death due to any cause.
Measure:Duration of overall Response (DoR)
Time Frame:15 months
Safety Issue:
Description:Time from first documented response (CR or PR) until documented disease progression or death due to lung cancer.
Measure:Evaluation of Safety profile
Time Frame:Up to 100 days after last study treatment administration
Safety Issue:
Description:Incidence of all AEs, SAEs according to CTCAE v4.03.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Transgene

Trial Keywords

  • Nivolumab
  • Therapeutic Vaccine

Last Updated

January 19, 2018