A study comparing standard therapy with or without TG4010 in patients with advanced non small cell lung cancer
- Conditions
- Stage IV non small cell lung cancer (NSCLC)MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001468-23-HU
- Lead Sponsor
- Transgene S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1018
- Male or female patients, age = 18 years old
- Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- Stage IV cancer according to TNM classification
- Tumor biopsy specimen with = 50% of MUC1 expressing tumor cells determined by Immunohistochemistry (IHC) staining on fixed pathological material; biopsy may come either from the primary tumor or from a metastasis
- Patient's naïve to first-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy 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, i.e., D1 of Cycle 1.
- At least one measurable lesion by computorized tomography scan or magnetic resonance imaging based on RECIST version 1.1 (CT is preferred for the chest exam)
- Performance status 0 or 1 on the ECOG scale
- Adequate hematological, hepatic, and renal function:
* Hemoglobin = 10.0 g/dL
* White Blood Cells = 3.0x1E+09/L including:
Neutrophils = 1.5x1E+09/L
Total lymphocytes count = 0.5x1E+09/L
* Platelets count = 100x1E+09/L
* Serum alkaline phosphatase = 3 x upper limit of normal (ULN) in the absence of liver or bone metastases, and = 5 x ULN in patients with such metastases
* Serum transaminases alanine aminotransferase and aspartate aminotransferase = 2.5 x ULN in the absence of liver metastases and = 5 x ULN in case of liver metastases
* Total bilirubin =1.5 x ULN
* Glomerular Filtration Rate = 60 mL/min (according to Modification of the Diet in Renal Disease (MDRD) formula or Cockroft & Gault formula)
* Serum albumin = 30 g/L
- Effective contraception during the study period and for 3 months after the last study treatment administration (male and female patient)
- Written informed consent
- For Phase III part: additional inclusion criterion for the level of TrPAL may be added according to the results observed in Phase IIb part
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 630
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 388
- Patients having Central Nervous System metastases. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed
- Documented EGFR activating mutations leading to eligibility for TKI treatment (if already tested)
- Prior history of other malignancy except:
* Basal cell carcinoma of the skin
* Cervical intra epithelial neoplasia
* Other cancer curatively treated with no evidence of disease for at least 5 years
- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment (i.e., D1 of Cycle 1)
- Positive serology for Human Immunodeficiency Virus or Hepatitis C Virus; presence in the serum of the antigens HBs
- 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)
- Patient with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1). However, prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted within the 4 weeks before treatment start
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:
* women whose sexual orientation precludes intercourse with a male partner
* women whose partners have been sterilized by vasectomy or other means
* using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices [IUDs]; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable)
- Patient with an organ allograft
- Known allergy to eggs, gentamicin or platinum containing compounds
- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1)
- Patient unable or unwilling to comply with the protocol requirements
- Bevacizumab will be allowed for patients with non-squamous carcinoma. Prescribing information must be followed and precautions have to be taken into consideration (e.g., patients having presented a serious hemorrhage or recent hemoptysis should not receive bevacizumab)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method