Patients with Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) Me
Conditions
Interventions
Product Name: Imprime PGG (PGG Beta Glucan)
Product Code: BTH 1677
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: L01XC06
Pharmac
Sponsors
Biothera
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be considered eligible to participate in the study, a subject must meet all of the inclusion criteria listed below. The subject: 1. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC); 2. Is between the ages of 18 and 75 years old, inclusive; 3. Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer; 4. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST; 5. Has an ECOG performance status of 0 or 1; 6. Has a life expectancy of > 3 months; 7. Has adequate hematologic function as evidenced by: a. ANC = 1,500/µL b. PLT = 100,000/µL c. HGB = 9 g/dL obtained within 1 week prior to the first dose of study medication; 8. Has adequate renal function as evidenced by: a. Serum creatinine = 1.5 X the upper limit of normal (ULN) for the reference lab b. Urine dipstick for proteinuria of =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below. The subject: 1. Has received prior systemic chemotherapy at any time for lung cancer; 2. Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1; 3. Has a known hypersensitivity to baker’s yeast, or has an active yeast infection; 4. Has had previous exposure to Betafectin® or Imprime PGG; 5. Has an active infection; 6. Presents with any of the following medical diagnoses/conditions at the time of screening: a. Central nervous system (CNS) metastases b. Peripheral neuropathy = grade 2 from any cause c. Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing d. Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician’s opinion could interfere with participation 7. Has a history of any of the following medical diagnoses/conditions: a. Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months b. Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intraepithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL 8. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab; 9. Has a know sensitivity to Cremophor EL; 10. Has previously received treatment with cetuximab; 11. If female, is pregnant or breast-feeding; 12. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication); 13. Has previously received an organ or progenitor/stem cell transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to assess the antitumor activity and safety of Imprime PGG® Injection (Imprime PGG) when used in the treatment of non-small cell lung cancer (NSCLC) patients. The primary objective of this study is: • To determine the objective response rate (ORR) in each study arm;Secondary Objective: The secondary objectives of this study are: • To determine the disease control rate (DCR) in each study arm • To determine the overall survival (OS) in each study arm • To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm • To determine the duration of objective tumor response in each study arm • To determine the duration of stable disease in each study arm • To determine the duration of time to progression (TTP) in each study arm • To assess the safety of the dosing regimen in each study arm • To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only);Primary end point(s): The primary endpoint of this study is: • Objective response rate (ORR) in each study arm;Timepoint(s) of evaluation of this end point: at least 4 completed cycles of three weeks each (total 12 weeks) and maximum of 18 cycles (total 54 weeks), before a subsequent Sponsor authorization is required in order to continue treatment under the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of this study are: • Disease control rate (DCR) for each study arm • Overall survival (OS) for each study arm • Complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm • Duration of objective tumor response in each study arm • Duration of stable disease in each study arm • Duration of time to progression (TTP) in each study arm | — |
Countries
Germany, United States
Contacts
Public ContactBettina Weiher
Ecron Acunova
Outcome results
None listed