Know Cancer

or
forgot password

International Multicenter Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of BCD-021 (CJSC BIOCAD, Russia) and Paclitaxel + Carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer (NSCLC) Patients


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

International Multicenter Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of BCD-021 (CJSC BIOCAD, Russia) and Paclitaxel + Carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer (NSCLC) Patients


Inclusion Criteria:



- Written informed consent;

- Newly diagnosed histologically or cytologically confirmed NSCLC excluding squamous
NSCLC (mixed cancer types should be classified according to the prevalent cell type);

- IIIb or IV stage of NSCLC (TNM classification version 6);

- Age ≥ 18 years and age ≤ 70 years (both inclusive);

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, (not
declining within 2 weeks prior to the first dose of investigational product);

- Life expectancy - 12 weeks or more from the moment of randomization;

- Presence of at least 1 measurable tumour with a size not less than 1 cm (revealed
with CT slice thickness not more than 5 mm), as defined by modified Response
Evaluation Criteria in Solid Tumors (RECIST) criteria (specifically, no ascites,
pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous
lymphangitis of the lung as only lesion;

- Patients should be able to follow the Protocol procedures (according to
Investigator's assessment);

- Patients must implement reliable contraceptive measures during all the study
treatment, starting 4 weeks prior to the administration of the first dose of
investigational product until 6 months after the last dose of investigational
product. This requirement does not apply to participants who have undergone surgical
sterilization, or patients who are postmenopausal (documented) for the past 2 years.
Reliable contraceptive measures include two methods of contraception, including one
barrier method

Exclusion Criteria:

- Squamous NSCLC;

- Proven coagulopathy, clinically significant hemorrhage in the past including nasal
hemorrhage;

- absolute neutrophil count <1500/mm3;

- Platelets <100 000/mm3;

- Hemoglobin < 90 g/L;

- Creatinine level ≥1.5 mg/dL;

- Bilirubin level ≥1.5 × upper limit of normal (ULN);

- Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ≥2.5 × ULN
(≥5 × ULN for patients with liver metastases);

- Alkaline phosphatase level ≥5 × ULN;

- Current therapeutic anticoagulation treatment, aspirin (more than 325 mg/day),
nonsteroidal anti-inflammatory drugs, antiplatelet agents or protracted treatment
with these drugs less than 1 month before entering the study;

- Uncontrolled hypertension comprising all cases of arterial hypertension when no
decrease in blood pressure could be achieved despite treatment with a combination of
3 antihypertensive drugs including one diuretic and non-medical correction methods
(low salt diet, physical exercise);

- Previous anticancer therapy of metastatic NSCLC;

- Radiation or hormone therapy within 21 days prior to randomization;

- Major surgery 28 days before inclusion into the study;

- Previous antiangiogenic therapy;

- Hypersensitivity to taxanes, platinum agents, recombinant murine proteins, contrast
agents, premedication agents specified by Protocol (dexamethasone, diphenhydramine,
ranitidine) or excipients of investigational products;

- NSCLC metastases in central nervous system excluding metastases non-progressing
without glucocorticosteroids within 4 weeks before inclusion into the trial;

- Cardiovascular system pathology (CHF stage III-IV according to New York Heart
Association (NYHA) classification);

- Pregnancy or lactation;

- Conditions limiting patient's adherence to Protocol requirements (dementia,
neurologic or psychiatric disorders, drug addiction, alcoholism and others);

- Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events
(CTCAE) v.4.0;

- Simultaneous participation in other clinical trials, previous participation in other
clinical trials within 30 days before entering into the trial, previous participation
in the same trial;

- Any other concomitant cancer revealed within 5 years prior to screening, except
curatively treated intraductal carcinoma in situ, curatively treated cervical
carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;

- Acute or active chronic infections;

- Hepatitis C virus, hepatitis B virus, HIV, or syphilis infections;

- Obstacles in intravenous administration of study drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

primary outcome measure for efficacy evaluation

Outcome Time Frame:

Day 127

Safety Issue:

No

Authority:

Russia: Ministry of Health of the Russian Federation

Study ID:

BCD-021-02

NCT ID:

NCT01763645

Start Date:

October 2012

Completion Date:

November 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • bevacizumab
  • pharmacokinetics
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location