ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03353675
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : March 16, 2018
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 PD-L1 by immunohistochemical (IHC) staining.

Condition or disease Intervention/treatment Phase
NSCLC Biological: TG4010 Drug: Chemotherapy Drug: Nivolumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
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 16, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

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 ]
    Proportion of patients whose best overall response is CR or PR using RECIST 1.1


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 15 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.

  2. Disease Control Rate (DCR) [ Time Frame: 15 months ]
    Proportion of patients whose best overall response is either CR, PR, or SD.

  3. Overall Survival (OS) [ Time Frame: 27 months ]
    Time from the date of first study treatment administration to the date of death due to any cause.

  4. Duration of overall Response (DoR) [ Time Frame: 15 months ]
    Time from first documented response (CR or PR) until documented disease progression or death due to lung cancer.

  5. Evaluation of Safety profile [ Time Frame: Up to 100 days after last study treatment administration ]
    Incidence of all AEs, SAEs according to CTCAE v4.03.



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.


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
  • 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

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


Contacts
Contact: Transgene EU, Clinical Operations Department + 33 (0) 3 88 27 91 00 clinical.trials@transgene.fr

Locations
United States, North Carolina
Charlotte Active, not recruiting
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Nashville Active, not recruiting
Nashville, Tennessee, United States, 37203
Belgium
Libramont Recruiting
Libramont, Belgium
Denmark
Herlev Not yet recruiting
Herlev, Denmark
France
Rennes Active, not recruiting
Rennes, France
Strasbourg Recruiting
Strasbourg, France
Hungary
Budapest Not yet recruiting
Budapest, Hungary
Szekesfehervar Not yet recruiting
Szekesfehervar, Hungary
Sponsors and Collaborators
Transgene
Bristol-Myers Squibb

Responsible Party: Transgene
ClinicalTrials.gov Identifier: NCT03353675     History of Changes
Other Study ID Numbers: TG4010.24
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Transgene:
Nivolumab
Therapeutic Vaccine

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs