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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353675
Recruitment Status : Completed
First Posted : November 27, 2017
Results First Posted : January 11, 2022
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Transgene

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Metastatic Biological: TG4010 Drug: Chemotherapy Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : February 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: TG4010/Chemotherapy/Nivolumab 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




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 15 months ]

    Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met.

    Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.



Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 28 months ]

    Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval.


  2. Disease Control Rate (DCR) [ Time Frame: 15 months ]
    Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD).

  3. Overall Survival [ Time Frame: 28 months ]

    Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause.

    The Kaplan-Meier estimator was used to estimate median OS and its confidence interval.


  4. Duration of Overall Response (DoR) [ Time Frame: 28 months ]
    Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer.

  5. Number of Participants With Adverse Events or Abnormalities [ Time Frame: 28 months ]
    The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Principal Inclusion Criteria:

  • Female or male patients age > 18 years-old
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 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 central nervous system (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 epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)- rearrangements leading to eligibility for tyrosine kinase inhibitor (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 hepatitis C virus (HCV); presence in the serum of the antigens hepatitis B (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 multigated acquisition (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353675


Locations
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United States, North Carolina
Charlotte
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Nashville
Nashville, Tennessee, United States, 37203
Belgium
Libramont
Libramont, Belgium
France
Créteil
Créteil, France
Mulhouse
Mulhouse, France
Rennes
Rennes, France
Strasbourg
Strasbourg, France
Hungary
Budapest
Budapest, Hungary
Szekesfehervar
Szekesfehervar, Hungary
Sponsors and Collaborators
Transgene
Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Transgene:
Study Protocol  [PDF] March 13, 2018
Statistical Analysis Plan  [PDF] November 13, 2019

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Responsible Party: Transgene
ClinicalTrials.gov Identifier: NCT03353675    
Other Study ID Numbers: TG4010.24
First Posted: November 27, 2017    Key Record Dates
Results First Posted: January 11, 2022
Last Update Posted: January 11, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Transgene:
Metastatic NSCLC
Advanced lung malignancy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action