Comparing Efficacy and Safety between CT-P16 and EU-approved Avastin in Patients with Metastatic or Recurrent Non-Squamous Non Small Cell Lung Cancer

Phase 1

Conditions: Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
MedDRA version: 20.0 Level: LLT Classification code 10079440 Term: Non-squamous non-small cell lung cancer System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-002147-28-HR

Lead Sponsor: CELLTRION, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 678

Inclusion Criteria

1. Patient (male or female) must be = 18 years of age.
2. Patient must have confirmed predominantly non-squamous non-small
cell lung cancer (nsNSCLC) by hematoxylin and eosin staining or
immunohistochemistry.
3. Patient must be diagnosed as recurrent disease or stage IV according
to the American Joint Committee on Cancer (AJCC) Lung Cancer Staging
8th edition. Stage IV is defined as below:
a. Separate tumor nodule(s) in a contralateral lobe, or
b. Tumor with pleural or pericardial nodules, or
c. Malignant pleural or pericardial effusion related to tumor, or
d. Single or multiple extrathoracic metastases in a single organ or in
multiple organs
4. Patient must have at least 1 measurable lesion by Response
Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Target lesions
situated in a previously irradiated area are considered measurable if
recurrence has been demonstrated in such lesions.
a. Tumor lesions: = 10 mm in long axis by computerized tomography
(CT) scan, or
b. Malignant lymph nodes: = 15 mm in short axis by CT scan
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1
6. Life expectancy > 6 months based on clinical judgement
7. Negative result in both epidermal growth factor receptor (EGFR)
mutation and anaplastic lymphoma kinase (ALK) rearrangement which is
confirmed by biopsy or cytology specimens.
8. Patient must have adequate organ function as follows. These tests
must be performed within 14 days prior to Day 1 of Cycle 1.
Bone marrow reserve:
a. Hemoglobin = 9.0 g/dL, and
b. Absolute neutrophil count = 1,500/mm3, and
c. Platelet count = 100,000/mm3
Hepatic:
a. Alkaline phosphatase, aspartate aminotransferase and alanine
aminotransferase = 3.0 × upper limit of normal (ULN) (= 5.0 × ULN with
liver metastasis), and
b. Total bilirubin = 1.5 × ULN
Renal:
a. Serum creatinine = 1.5 × ULN, and
b. Creatinine clearance (CrCl) rate = 45 mL/min, and
c. Urine dipstick for proteinuria < 1+ (i.e., either 0 or trace); if urine
dipstick is = 1+ then < 1.0 g of protein in 24 hours urine collection must
be confirmed to allow participation in the study
9. Patient and their partner of childbearing potential must agree to use
acceptable birth control methods throughout the study and for 6 months
after the last dose of assigned treatment
A man or woman is of childbearing potential if, in the opinion of the
investigator, he or she is biologically capable of having children and is
sexually active. Male and female patients and their partners who have
been surgically sterilized for less than 24 weeks prior to the date of
informed consent must agree to use any medically acceptable methods

Exclusion Criteria

1. Patient who has predominantly squamous cell histology non-small cell
lung cancer (NSCLC). If small cell elements are present, the patient is
ineligible.
2. Patient who has clinically significant third-space fluid; for example,
ascites or pleural effusions that cannot be controlled by drainage or
other procedures prior to Day 1 of Cycle 1.
3. Patient who has untreated central nervous system (CNS) metastases
or CNS metastasis with bleeding risk at investigator's discretion and/or
leptomeningeal disease. However, treated and clinically stable
(asymptomatic; off steroids) brain metastases are allowed.
4. Patient who has invasion of major blood vessels. Patient with a tumor
cavitation in the opinion of the investigator is likely to bleed will be
excluded as well.
5. Patient who has received previous anti-cancer systemic therapy:
Cytotoxic chemotherapy for metastatic nsNSCLC, Cytotoxic
chemotherapy for non-metastatic nsNSCLC within 12 months prior to
Day 1 of Cycle 1, Anti-neoplastic biological therapy, immunotherapy or
targeted therapy, Bevacizumab (or a bevacizumab proposed biosimilar
product).
6. Patient who has received previous surgical procedure including:
Surgery for metastatic nsNSCLC, Surgery for non-metastatic nsNSCLC
within 6 months prior to Day 1 of Cycle 1, Open biopsy or open
pleurodesis within 28 days prior to Day 1 of Cycle 1, Core biopsy or other
minor surgical procedure (e.g. placement of vascular access device,
closed pleurodesis, thoracentesis, and mediastinoscopy) within 14 days
prior to Day 1 of Cycle 1.
7. Patient who has received previous anti-cancer radiotherapy including
one or more of the following(s):
a. Radiotherapy for metastatic nsNSCLC, but radiotherapy as part of the
palliative therapy and/or treatment for CNS metastases completed at
least 14 days prior to Day 1 of Cycle 1 is allowed,
b. Radiotherapy for non-metastatic nsNSCLC within 6 months prior to
Day 1 of Cycle 1,
c. Any toxicity related with radiotherapy prior to Day 1 of Cycle 1.
8. Patient who has a medical history of disease including one or more of
the following(s):
a. Clinically significant allergic reactions such as asthma, urticaria,
angio-oedema, and eczematous dermatitis, hypersensitivity to any
component of carboplatin, paclitaxel, bevacizumab and Chinese Hamster
Ovary (CHO) cell products or other recombinant human or humanized
antibodies.
b. Cardiac, gastrointestinal, renal, hepatic, hematological (including
pancytopenia, aplastic anemia or blood dyscrasia), metabolic (including
known diabetes mellitus), autoimmune disease, or pulmonary diseases
classed as significant in the opinion of the investigator.
c. A known infection with hepatitis B (active or carrier of hepatitis B

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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