AN EQUIVALENCE TRIAL TO COMPARE THE EFFICACY, SAFETY, PHARMACOKINETICS AND IMMUNOGENICITY OF HD204 TO AVASTIN® IN PATIENTS WITH LUNG CANCER.
- Conditions
- on-squamous Non-small Cell Lung Cancer (nsNSCLC)MedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-005175-78-GR
- Lead Sponsor
- Prestige BioPharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 650
1. Able and willing to give written informed consent.
2. Aged = 18 years of age.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS)
of 0-1 and life expectancy >3 months based on Investigator's
judgement.
4. Histologically confirmed metastatic Stage IV or recurrent non
squamous non-small cell lung cancer (NSCLC) that is no longer
amendable to curative surgery or local therapy.
5. At least one measurable lesion according to RECIST v.1.1. as
confirmed by CIR; bone-only and brain-only metastases are not allowed.Lesions previously treated with radiotherapy are non-target lesions
unless clear progression was documented. Previous results are
acceptable if performed within 4 weeks prior to screening.
6. No first line treatment for metastatic or recurrent disease. Prior
systemic therapy and/or radiotherapy for locally advanced disease is
permitted if completed = 6 months prior to the diagnosis of relapsing
disease.
7. Tumors without EGFR mutation or ALK receptor alteration. Patients
with unknown mutation status or known EGFR mutation or ALK receptor
alteration may be included provided the corresponding targeted agent is
not available and chemotherapy is the standard of care of the study
center.
8. Adequate hematological function, defined as:
a. Platelet count: = 100,000/µL without the need for transfusion in the 2
weeks prior to Screening.
b. Prothrombin time (PT), International normalized ratio (INR) or
activated partial thromboplastin time (aPTT) =1.5 x the upper limit of
normal (ULN).
c. Absolute neutrophil count: = 1,500/µL without any medical
interventionaltreatment (ie, granulocyte-colony stimulating factors [GCSFs]
and/or herbal remedies).
d. Hemoglobin: = 9 g/dL, without the need for transfusion in the 2
weeks prior to Screening.
9. Adequate hepatic function as evidenced by meeting all of the
following requirements:
a. Total bilirubin: = 1.5 x ULN.
b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT),
and alkaline phosphatase (ALP): = 3 x ULN.
c. If liver metastases are present, ALT and AST = 5 x ULN; if liver and/or
bone metastases are present ALP = 5 x ULN.
10. Adequate renal function, as evidenced by meeting all of the following
requirements:
a. Serum creatinine = 1.5 x ULN and creatinine clearance > 50
mL/minute or estimated glomerular filtration rate (GFR) >50
mL/minute.
b. Urine dipstick for proteinuria of less than 2+ (other ways of urinalysis
are also acceptable); if urine dip stick is = 2+, proteinuria must be < 2
g in 24 hours or an equivalent protein/creatinine ratio of <2000 mg/g
creatinine (or < 226.0 mg/mmoL creatinine).
11. Female patients with childbearing potential (excluding women who
have undergone surgical sterilization or menopause. Menopause is
defined as the status where no menstrual periods continue for 1 year or
more without any other medical reasons), are eligible if they have
negative serum pregnancy testing within 7 days
prior to first dosing and are willing to use an effective method of birth
control/contraception to prevent pregnancy until 6 months after the end
of study. Male patients must consent using effective method of
contraception until 6 months after the end of 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 520
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130
1. Diagnosis of small cell carcinoma of the lung or mixed tumors
including small cell
carcinoma.
2. Known ROS-1 positive tumor, except in scenarios where the
corresponding target agent is not available, and chemotherapy is the
standard of care at the study center. Patients with ROS-1 status not
known at all can be considered as eligible for the study.
3. Tumor cavitation, tumor invading into large blood vessels or close to
large vessels with high risk of bleeding, according to Investigator's judgment.
4. Prior therapy with monoclonal antibodies or small molecule inhibitors
against VEGF
or VEGFR.
5. Prior systemic anticancer therapy, or radiotherapy for locally
advanced nsNSCLC if
completed < 6 months prior to the diagnosis of relapsing disease.
6. Previous malignancy other than NSCLC in the last 5 years except for
basal cell carcinoma
of the skin or pre-invasive cancer of the cervix.
7. Known brain metastasis or other CNS metastasis that is either
symptomatic or
untreated. Metastases that have been treated by complete resection
and/or
radiotherapy demonstrating stability or improvement are not an
exclusion criterion
provided they are stable as shown by computed tomography (CT) or
magnetic
resonance imaging (MRI) scan for at least 4 weeks before Screening
without evidence
of cerebral edema. Patients on stable dose of corticosteroids or
anticonvulsants are
permitted.
8. Any unresolved toxicity > Grade I (except alopecia) from previous
anticancer therapy
(including radiotherapy).
9. History of hemoptysis (> 1/2 teaspoon per event over the past 6
months) or evidence
of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
Clinically
non-significant minor bleeding is acceptable.
10. A significant thrombotic or hemorrhagic event = 6 months prior to
Screening (includes
hemoptysis [> 2.5 mL of red blood], gastrointestinal bleeding,
hematemesis, CNS
hemorrhage, severe epistaxis or vaginal bleeding, cerebral infarction,
transient
ischemic attacks, myocardial infarction, unstable angina, and
uncontrolled coronary artery
disease).
11. Clinically serious non-healing wounds, or incompletely healed bone
fracture at
screening.
12. Known hypersensitivity to any of the study drugs or their excipients,
or history of
clinically significant atopic allergy (eg, asthma including childhood
asthma, urticarial).
13. Live/attenuated vaccine within 12 weeks prior to the Screening Visit.
14. History of myocardial infarction (= 6 months prior to Screening),
unstable angina, New
York Heart Association Grade II or greater, congestive heart failure, or
serious cardiac
arrhythmia requiring medication.
15. History of poorly controlled hypertension or resting blood pressure
>150/100 mmHg
in the presence of a stable regimen of antihypertensive therapy.
16. Any major surgical procedure (risk of bleeding or wound healing
complications) within
28 days prior to the screening.
17. History of active gastroduodenal ulcer, abdominal fistula as well as
nongastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within
6 months prior to Screening. However, patient with history of ulcer
which had been treated could be considered as eligible for the study.
18. Clinically significant active infection requiring systemic therapy.
19. Known active Hepatitis B infection (according to local site standards)
or active Hepatitis C infection (Hepatitis C virus [HCV] antibody
positive); the patient could be included in the study if he/she is HCV RNA
ne
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