Patients with with Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer MedDRA version: 17.1 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: 17.1 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)
Conditions
Interventions
Product Name: Imprime PGG (PGG Beta Glucan, BTH 1677)
Product Code: 152521-52-3
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Avastin
Product Name: Bevacizumab
Pharmaceutical
Sponsors
Biothera
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and Main Criteria for Inclusion in the Study: 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 non-squamous, non-small cell lung cancer 5. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST version 1.0; 6. Has an ECOG performance status of 0 or 1; 7. Has a life expectancy of > 3 months; 8. 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; 9. 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
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. Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control c. Peripheral neuropathy = grade 2 from any cause d. Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing e. 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. Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic attack or cerebral infarction b. Deep vein thrombosis within 1 year prior to screening c. 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 d. Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intraepithelial neoplasia or curatively treated prostate cancer with a PSA of 100 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function within 1 week of Day 1; 16. Presents with any of the following medical diagnoses/conditions at the time of screening: a. Predominant squamous cell histology 17. Has a history of any of the following medical diagnoses/conditions: a. Hemoptysis (= ½ tsp red blood) b. Bleeding diathesis or coagulopathy 18. If female, is pregnant or breast-feeding; 19. 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); 20. 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® Injections (Imprime PGG) when used in combination with a monoclonal antibody and concomitant chemotherapy in non-small cell lung cancer (NSCLC). The primary objective is: • To determine the objective response rate (ORR) in each arm;Secondary Objective: • 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: Subjects will initially be eligible to receive up to 18 cycles of treatment. With each treatment cycle lasting 3 weeks, the maximum duration of treatment will be 54 weeks, without a treatment extension being authorized by the Sponsor. Patients who continue to experience a stable, partial or complete response (according to RECIST 1.0) following completion of the 18th treatment cycle, will be evaluated on a case-by-case basis by the investigator, the Medical Monitor and the study Sponsor to determine eligibility for extending their treatment under this protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of this study are: o To determine the disease control rate (DCR) in each study arm o To determine the overall survival (OS) in each study arm o To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm o To determine the duration of objective tumor response in each study arm o To determine the duration of stable disease in each study arm o To determine the duration of time to progression (TTP) in each study arm o To assess the safety of the dosing regimen within each study arm o To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only);Timepoint(s) of evaluation of this end point: Subjects will initially be eligible to receive up to 18 cycles of treatment. With each treatment cycle lasting 3 weeks, the maximum duration of treatment will be 54 weeks, without a treatment extension being authorized by the Sponsor. Patients who continue to experience a stable, partial or complete response (according to RECIST 1.0) following completion of the 18th treatment cycle, will be evaluated on a case-by-case basis by the investigator, the Medical Monitor and the study Sponsor to determine eligibility for extending their treatment under this protocol. | — |
Countries
Germany, United States
Contacts
Public ContactBettina Weiher
Ecron Acunova
Outcome results
None listed