A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination with Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients with Previously Untreated Advanced (Stage IIIB or IV)Non-Small Cell Lung Cancer

Phase 1

• Conditions: Patients with Previously Untreated Advanced (Stage IIIB or IV)Non-Small Cell Lung Cancer; MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10061773Term: Coagulation factor VIII level abnormalSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006778-14-DE
• Lead Sponsor: Biothera

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-03
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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 < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1
If urine dipstick is = 1+, then urine protein excretion must be = 500 mg over a 24 hour collection
obtained within 1 week prior to the first dose of study medication;
9. Has adequate hepatic function as evidenced by:
a. Serum total bilirubin = 1.0 mg/dL
b. AST = 2.5X ULN for the reference lab (= 5X ULN for subjects with known hepatic metastases)
c. ALT = 2.5X ULN for the reference lab (= 5X ULN for subjects with known hepatic metastases)
obtained within 1 week prior to the first dose of study medication;
10. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form
of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified