Stage IIIB-IV non small cell lung cancer (NSCLC) MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000015841
Conditions
Interventions
Product Name: Mesmulogene ancovacivec
Product Code: TG4010
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Mesmulogene ancovacivec
Other descriptive name: MVATG9931
Concentration u
Sponsors
Transgene S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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 co-stimulation 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 any of the following 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-tumor activity in terms of objective response rate (ORR) by using RECIST 1.1 in chemotherapy-naïve and immunotherapy-naïve advanced, non-squamous NSCLC patients with PD-L1 membrane staining on <50% of tumor cells receiving first-line chemotherapy (pemetrexed + carboplatin or cisplatin followed by pemetrexed maintenance therapy) plus TG4010 and nivolumab.;Secondary Objective: • To evaluate the efficacy with respect to: a) Progression Free Survival (PFS) b) Disease Control Rate (DCR) c) Overall Survival (OS) • To describe duration of response (DoR) • To evaluate the safety profile ;Primary end point(s): • Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: ORR: tumor assessment evaluated by RECIST 1.1 every 6 weeks from start of treatment until documented progression or for a period of 9 months after start of study treatment, whichever occurs first. Beyond 9 months of treatment, the evaluations will be performed every 12 weeks until documented progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression Free Survival (PFS) • Disease Control Rate (DCR) • Overall Survival (OS) • Duration of response (DoR) • Safety profile ;Timepoint(s) of evaluation of this end point: PFS, DCR, DoR: tumor assessment evaluated by RECIST 1.1 every 6 weeks from start of treatment until documented progression or for a period of 9 months after start of study treatment, whichever occurs first. Beyond 9 months of treatment, the evaluations will be performed every 12 weeks until documented progression OS: after termination of study treatment, patients will be followed for survival on a 3-monthly basis Safety: evaluated throughout the study | — |
Countries
Belgium, Denmark, France, Hungary, United States
Contacts
Public ContactMedical Affairs Secretariat
Transgene S.A.
Outcome results
None listed