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CompletedNCT00874848Updated Nov 29, 2016Results posted

Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer

A Phase 2 interventional study of Imprime PGG Injection and Cetuximab in NSCLC, sponsored by HiberCell, Inc.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by HiberCell, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.

02

Conditions studied

  • NSCLC

Keywords

  • Imprime PGG
  • NSCLC
  • Cetuximab
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 90 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

HiberCell, Inc. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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:

    • ANC ≥ 1,500/μL
    • PLT ≥ 100,000/μL
    • HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;

  8. Has adequate renal function as evidenced by:

    • Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
    • 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:

    • Serum total bilirubin ≤ 1.0 mg/dL
    • AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
    • 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.

Exclusion criteria

Exclusion Criteria:

  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:

    • Central nervous system (CNS) metastases
    • Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
    • Peripheral neuropathy ≥ grade 2 from any cause
    • Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
    • 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:

    • 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
    • Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Imprime PGG

    Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin

    Biological: Imprime PGG Injection · Biological: Cetuximab · Drug: Paclitaxel · Drug: Carboplatin

  • Active comparator
    Control

    Cetuximab + Paclitaxel/Carboplatin

    Biological: Cetuximab · Drug: Paclitaxel · Drug: Carboplatin

Interventions

  • BiologicalImprime PGG Injection

    4 mg/kg i.v. over 2 hrs, weekly, in three week cycles

  • BiologicalCetuximab

    initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle

    Also known as: Erbitux

  • DrugPaclitaxel

    200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles

    Also known as: Abraxane, Taxol, Onxol, Nov-Onxol

  • DrugCarboplatin

    dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles

    Also known as: Paraplatin

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review

    Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

    Time frame: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

Secondary outcomes

  1. Overall Survival (OS) in Each Study Arm Based on the Safety Population

    Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.

    Time frame: From the time of randomization to death, subject being lost to follow-up or study completion

  2. Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review

    The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

    Time frame: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

  3. Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review

    The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

    Time frame: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

  4. Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review

    The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

    Time frame: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

  5. Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review

    Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator. If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date.

    Time frame: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months

07

Results

Posted Nov 29, 2016

Participant flow

A randomized, Simon 2-stage flexible design with 22 patients enrolled in stage 1 and 68 additional patients in stage 2, for a total of 90 subjects (60 in the Imprime PGG arm and 30 in the Control arm) enrolled competitively across US and German clinical sites. First subject enrolled: 17 Aug 2009 Last subject last visit: 15 Nov 2012

Participant flow — Overall Study
MilestoneImprime PGG ArmControl Arm
Started5929
Discontinued5928
Completed01
Not completed5928
Withdrew: Adverse event132
Withdrew: Progressive neoplastic disease3818
Withdrew: Withdrawal by subject74
Withdrew: Noncompliance11
Withdrew: Failure to comply with protocol01
Withdrew: Physician decision02

Outcome measures

PrimaryObjective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review

Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

Time frame:
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Reported as:
Number · participants
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
participantsImprime PGG ArmControl Arm
Number of participants with best response of CR00
Number of participants with best response of PR156
Statistical analysis
  • Imprime PGG Arm vs Control Arm · Fisher Exact · p = 0.2895
SecondaryOverall Survival (OS) in Each Study Arm Based on the Safety Population

Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.

Time frame:
From the time of randomization to death, subject being lost to follow-up or study completion
Reported as:
Median · months
Overall Survival (OS) in Each Study Arm Based on the Safety Population
monthsImprime PGG ArmControl Arm
Overall Survival (OS) in Each Study Arm Based on the Safety Population10.3 (8.6 to 15.1)12.4 (9.3 to 17.4)
SecondaryDisease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review

The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

Time frame:
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Reported as:
Number · participants
Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review
participantsImprime PGG ArmControl Arm
Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review3521
SecondaryComplete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review

The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

Time frame:
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Reported as:
Number · participants
Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
participantsImprime PGG ArmControl Arm
Number of participants with best response of CR00
Number of participants with best response of PR156
Number of participants with best response of SD2015
SecondaryDuration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review

The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

Time frame:
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Reported as:
Median · months
Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review
monthsImprime PGG ArmControl Arm
Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review4.4 (2.8 to 6.5)4.1 (1.4 to 5.4)
SecondaryDuration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review

Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator. If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date.

Time frame:
From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
Reported as:
Median · months
Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review
monthsImprime PGG ArmControl Arm
Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review6.4 (4.3 to 8.3)6.0 (4.3 to 7.1)

Adverse events

Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Imprime PGG Arm—37/59 (62.7%)59/59 (100%)
Control Arm—12/29 (41.4%)29/29 (100%)
Most frequent serious events
Showing 10 of 65
Most frequent serious events
EventImprime PGG ArmControl Arm
Pleural effusionRespiratory, thoracic and mediastinal disorders6/590/29
Pulmonary embolismRespiratory, thoracic and mediastinal disorders5/592/29
NeutropeniaBlood and lymphatic system disorders1/592/29
DiarrhoeaGastrointestinal disorders0/592/29
AnaemiaBlood and lymphatic system disorders1/591/29
ThrombocytopeniaBlood and lymphatic system disorders0/591/29
Acute myocardial infarctionCardiac disorders0/591/29
Hypertrophic cardiomyopathyCardiac disorders0/591/29
AstheniaGeneral disorders0/591/29
Disease progressionGeneral disorders0/591/29
Most frequent other events
Showing 10 of 86
Most frequent other events
EventImprime PGG ArmControl Arm
RashSkin and subcutaneous tissue disorders28/5919/29
FatigueGeneral disorders30/5917/29
NeutropeniaBlood and lymphatic system disorders22/5914/29
AlopeciaSkin and subcutaneous tissue disorders22/5913/29
NauseaGastrointestinal disorders25/5912/29
DiarrhoeaGastrointestinal disorders24/599/29
CoughRespiratory, thoracic and mediastinal disorders12/5911/29
ConstipationGastrointestinal disorders11/5910/29
DyspnoeaRespiratory, thoracic and mediastinal disorders10/5910/29
LeukopeniaBlood and lymphatic system disorders13/599/29

Baseline characteristics

The safety population comprised all randomized participants who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.

Age, Continuous
Age, Continuous(Years)Imprime PGG ArmControl ArmTotal
Mean59.3 ± 9.4562.4 ± 7.0460.45 ± 8.81
Sex: Female, Male
Sex: Female, Male(Participants)Imprime PGG ArmControl ArmTotal
Female151227
Male441761
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Imprime PGG ArmControl ArmTotal
White562985
Black202
Other101
Region of Enrollment
Region of Enrollment(participants)Imprime PGG ArmControl ArmTotal
United States426
Germany552782
ECOG
ECOG(participants)Imprime PGG ArmControl ArmTotal
Score = 0201030
Score = 1381856
Missing112
Baseline Height
Baseline Height(cm)Imprime PGG ArmControl ArmTotal
Mean171.1 ± 7.51170.0 ± 8.90170.8 ± 7.96
Baseline Weight
Baseline Weight(kg)Imprime PGG ArmControl ArmTotal
Mean76.2 ± 16.5272.8 ± 12.1975.0 ± 15.24
Baseline Body Mass Index
Baseline Body Mass Index(kg/m^2)Imprime PGG ArmControl ArmTotal
Mean25.9 ± 4.9525.1 ± 3.0025.6 ± 4.40

2 further baseline measures are reported on the registry.

08

Study locations

14 sites
  • Medical College of Georgia
    Augusta, Georgia 30912, United States
  • Providence Medical Group
    Terre Haute, Indiana 47802, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Mary Crowley Medical Research Center
    Dallas, Texas 75201, United States
  • Allison Cancer Center
    Midland, Texas 79701, United States
  • Helios Clinic Emil von Behring
    Berlin, Germany
  • Municipal Clinic Frankfurt Hoescht
    Frankfurt, Germany
  • Georg-August University Gottingen
    Gottingen, 37075, Germany
  • University Clinical Heidelberg
    Heidelberg, Germany
  • Clinic Minden
    Minden, Germany
  • Techincal University of Munich
    Munich, Germany
  • Clinic Nurnberg Nord
    Nuremberg, Germany
  • Universitätsklinikum Ulm
    Ulm, 89081, Germany
  • HELIOS Klinikum Wuppertal, Medizinische Klinik 1
    Wuppertal, 42283, Germany
09

References and documents

Publications

  • Thomas M, Sadjadian P, Kollmeier J, Lowe J, Mattson P, Trout JR, Gargano M, Patchen ML, Walsh R, Beliveau M, Marier JF, Bose N, Gorden K, Schneller F 3rd. A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. Invest New Drugs. 2017 Jun;35(3):345-358. doi: 10.1007/s10637-017-0450-3. Epub 2017 Mar 16. PubMed 28303530 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00874848
Lead sponsor
HiberCell, Inc.
Responsible party
Sponsor
First posted
Apr 3, 2009
Start date
Aug 2009
Primary completion
Nov 2012
Completion
Aug 2015
Results posted
Nov 29, 2016
Last update
Nov 29, 2016

Study contacts

Folker Schneller, MD
principal investigator · Technical University, Munich

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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