Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Georgia
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Augusta, Georgia, Forenede Stater, 30912
- Medical College of Georgia
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Indiana
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Terre Haute, Indiana, Forenede Stater, 47802
- Providence Medical Group
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
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Texas
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Dallas, Texas, Forenede Stater, 75201
- Mary Crowley Medical Research Center
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Midland, Texas, Forenede Stater, 79701
- Allison Cancer Center
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Berlin, Tyskland
- Helios Clinic Emil von Behring
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Frankfurt, Tyskland
- Municipal Clinic Frankfurt Hoescht
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Gottingen, Tyskland, 37075
- Georg-August University Göttingen
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Heidelberg, Tyskland
- University Clinical Heidelberg
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Minden, Tyskland
- Clinic Minden
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Munich, Tyskland
- Techincal University of Munich
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Nuremberg, Tyskland
- Clinic Nurnberg Nord
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Ulm, Tyskland, 89081
- Universitätsklinikum Ulm
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Wuppertal, Tyskland, 42283
- HELIOS Klinikum Wuppertal, Medizinische Klinik 1
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
- Is between the ages of 18 and 75 years old, inclusive
- Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
- Has an ECOG performance status of 0 or 1
- Has a life expectancy of > 3 months
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;
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;
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;
- 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:
- Has received prior systemic chemotherapy at any time for lung cancer;
- Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection
- Has had previous exposure to Betafectin® or Imprime PGG
- Has an active infection
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
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
- Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
- Has a know sensitivity to Cremophor EL
- Has previously received treatment with cetuximab
- If female, is pregnant or breast-feeding
- 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)
- Has previously received an organ or progenitor/stem cell transplant.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
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4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
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
Andre navne:
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
Andre navne:
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
Andre navne:
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Aktiv komparator: Control
Cetuximab + Paclitaxel/Carboplatin
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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
Andre navne:
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
Andre navne:
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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Tidsramme: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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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. |
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival (OS) in Each Study Arm Based on the Safety Population
Tidsramme: From the time of randomization to death, subject being lost to follow-up or study completion
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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.
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From the time of randomization to death, subject being lost to follow-up or study completion
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Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review
Tidsramme: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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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. |
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
Tidsramme: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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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. |
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
|
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Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review
Tidsramme: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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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. |
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review
Tidsramme: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
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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. |
From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Folker Schneller, MD, Technical University, Munich
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Carboplatin
- Paclitaxel
- Albumin-bundet Paclitaxel
- Cetuximab
Andre undersøgelses-id-numre
- BT-CL-PGG-LCA0822
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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