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A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

Phase 2/Phase 3
18 Years
Open (Enrolling)
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

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

- Stage IV cancer according to TNM classification (7th edition - UICC, December 2009;
includes tumor with malignant pleural or pericardial effusion

- 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. Cytological material is not
accepted for this analysis

- 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 CT scan or MRI based on RECIST version 1.1

- PS 0 or 1 on the ECOG scale

- Adequate hematological, hepatic, and renal function:

- Hemoglobin ≥ 10.0 g/dL

- White Blood Cells (WBC) ≥ 3.0x10E9/L including

- Neutrophils ≥ 1.5x109/L

- Total lymphocytes count ≥ 0.5x10E9/L

- Platelets count ≥ 100x10E9/L

- Serum alkaline phosphatase ≤ 3x ULN (upper limit of normal)in the absence of
liver or bone metastases or ≤5 ULN(in patients with documented bone or liver

- Serum transaminases (alanine aminotransferase [ALT] and aspartate
aminotransferase [AST]) ≤ 2.5 x ULN in the absence of liver metastases or =< 5
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)

Exclusion Criteria:

- Patients having Central Nervous System (CNS) metastases. Patients who have had brain
metastases surgically removed or irradiated with no residual disease confirmed by
imaging are allowed

- Documented EGFR activating mutations (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 (HIV) or Hepatitis C Virus (HCV);
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). Prior surgery or radiation therapy aimed at
local palliation or attempted local disease control is permitted

- 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

- Pregnancy or lactation

- 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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Phase 2: Progression-free Survival (PFS)

Outcome Description:

PFS is measured from date of randomization to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.

Outcome Time Frame:

Approximately 15 months

Safety Issue:


Principal Investigator

QUOIX Elisabeth, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpitaux Universitaires de Strasbourg


European Union: European Medicines Agency

Study ID:




Start Date:

January 2012

Completion Date:

December 2016

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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Massachusetts General HospitalCambridge, Maryland  2114
Oncology/Hematology P.C.Rockville, Maryland  20850
Highlands Oncology GroupFayetteville, North Carolina  72703
ProMedica Health System IncToledo, Ohio  43606
Abington Hematology Oncology Associates IncWillow Grove, Pennsylvania  19090
Texas Oncology, P.A. - Abilene (South)Abilene, Texas  79606