A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    512
  • sponsor
    Shanghai Institute Of Biological Products
Updated on 22 April 2022

Summary

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Description

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. The study was divided into three stages: screening stage, treatment stage (combined chemotherapy stage, single drug maintenance treatment stage, visit after treatment) and follow-up stage (survival follow-up after disease progression). To evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Details
Condition Non-squamous Non-small-cell Lung Cancer
Treatment carboplatin, Paclitaxel, Avastin, SIBP04
Clinical Study IdentifierNCT05318443
SponsorShanghai Institute Of Biological Products
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subjects voluntarily joined the trial and signed the informed consent form
Age≥18 years old and≤75 years old (subject to the date of signing the informed consent form), male or female
Non-squamous non-small cell lung cancer confirmed by histology or cytology (excluding sputum cytology), and according to the International Association for the Study of Lung Cancer (IASLC) eighth edition staging criteria, evaluated as stage IIIB-IV inoperable treatment or locally advanced, recurrent or metastatic subjects who cannot receive radical radiotherapy or refuse radical radiotherapy; if there are multiple tumor components, they should be classified according to their main cell types
EGFR, ALK, ROS-1 positive patients can be enrolled voluntarily, and the subjects need to provide the test results report of the above genes (If the subject fails to provide the EGFR, ALK, ROS-1 gene test report, he or she must provide tissue sections or tumor specimens for testing in this research center or a tertiary hospital. When the driver gene is unknown, the investigator and the subject jointly decide whether to join the group)
At least one evaluable target lesion confirmed by imaging (evaluated according to RECIST 1.1 criteria)
ECOG PS score is 0-1
Expected survival time ≥ 6 months
No systematic anti-tumor treatment for locally advanced or metastatic non-squamous non-small cell lung cancer [Subjects can be enrolled if they receive adjuvant therapy after completing curative treatment for early-stage non-small cell lung cancer, but have disease recurrence. In this case, the end time of adjuvant therapy is required to be more than 6 months after the first administration of this study, and the various toxic reactions caused by adjuvant therapy have recovered (judged by CTCAE 5.0 standard ≤ grade 1, except for alopecia ) or a new lesion appeared 6 months after the end of radical radiotherapy in stage IIIB patients]
Laboratory results at screening
Blood routine: white blood cell count≥3.5×109/L, absolute value of neutrophil ≥1.5×109/L
platelet count ≥100×109/L, hemoglobin ≥100g/L; Liver function: total bilirubin ≤1.5× upper
limit of normal (ULN); subjects without liver metastases had alanine aminotransferase (ALT)
and aspartate aminotransferase (AST) ≤2.5×ULN; liver Metastatic subjects with ALT and AST ≤
×ULN; Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥ 55mL/min, and
urine routine test results show urine protein <2+, for subjects whose urine routine test
shows urine protein ≥2+ at baseline, 24 hours urine collection should be performed and
protein content in urine <1.0g within 24 hours; Coagulation function: International
Normalized Ratio (INR) ≤1.5, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN
Female subjects of childbearing age, male subjects and male subjects' partners agree
to use reliable contraceptive measures from the time of signing the informed consent
to 6 months after the end of the last trial drug infusion (such as abstinence, or
physical contraception, or hormonal contraception, etc.)
Subjects need to communicate well with the investigator, and be able to follow the
visit, treatment, laboratory examination and other relevant regulations

Exclusion Criteria

Subjects with non-small cell lung cancer of other pathological histological types
[including squamous cell carcinoma, mixed non-small cell and small cell lung cancer
and lung adenosquamous carcinoma with squamous cell carcinoma predominant]
Malignant tumors other than lung cancer within 5 years, excluding cured cervical
carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer
after radical resection, and breast ductal carcinoma in situ after radical resection
etc
Left ventricular ejection fraction (LVEF) < 50% by color Doppler echocardiography
Imaging examination at the screening stage show that the tumor approaches, surrounds
or invades the lumen of a large vessel (eg, the pulmonary artery or superior vena
cava)
Subjects with high suspicion of idiopathic pulmonary fibrosis, organizing pneumonia
drug-related pneumonia, idiopathic pneumonia, active pneumonia or active pulmonary
tuberculosis by chest imaging examination during the screening stage
Previous history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled
hypertension (systolic blood pressure>150mmHg, and/or diastolic blood
pressure>100mmHg)
Any unstable systemic disease within 6 months prior to randomization: Including but
not limited to cerebrovascular accident or transient ischemic attack, unstable angina
pectoris, myocardial infarction, congestive heart failure [New York Heart Association
(NYHA) grade ≥ grade II], severe arrhythmia requiring drug treatment, etc
There are serious unhealed wounds or fractures, or major surgery (including
thoracotomy, or major surgery is expected during the study period) within 28 days
before randomization; For major surgery, refer to the 3rd and 4th grade surgery
stipulated in the "Administrative Measures for the Classification of Surgery in
Medical Institutions (Trial)
Subjects who have undergone minor surgery within 48 hours before randomization, and
who are judged by the investigator to have a bleeding tendency
Subjects who have a history of chest radiotherapy within 28 days before randomization
or those who have received palliative radiotherapy for bone metastases within 14 days
before randomization
History of the following within 6 months before randomization: peptic ulcer
gastrointestinal perforation, erosive esophagitis or gastritis, inflammatory bowel
disease or diverticulitis, abdominal fistula, or intra-abdominal abscess
Definite diagnosis of tracheoesophageal fistula
Bleeding tendency, high bleeding risk, or coagulation disorder, including history of
hemoptysis within 3 months before screening (single hemoptysis ≥ 2.5 ml bright red
blood),or recently (≤10 days from first dose of study drug) full-dose oral or
parenteral anticoagulants or thrombolytics or aspirin (>325 mg/day) or other
non-steroidal anti-inflammatory drugs that inhibit platelet function; or have
undergone surgery before, and the investigator judges that they have bleeding
tendency
Subjects with known central nervous system metastases (except for the subjects with
asymptomatic brain metastases and whose symptoms were controlled after treatment and
stable within 1 month before randomization)
Serious infection (including but not limited to infection requiring hospitalization
bacteremia, severe pneumonia, etc.) occurred within 28 days before randomization
A history of vascular disease requiring surgical repair within 6 months prior to
randomization, such as aortic aneurysm or arterial thrombosis
Known to be allergic to SIBP04, Avastin®, Paclitaxel, Carboplatin injection or their
excipients
Known history of autoimmune disease, allergic disease or allergic constitution
(allergic to two or more foods and drugs)
Received any other experimental drug treatment or participated in another
interventional clinical trial within 3 months before screening
In the screening stage, Hepatitis B surface antigen was positive, and the level of
hepatitis B virus DNA (HBV-DNA) in peripheral blood was higher than the reference
value or lower limit of detection method; Hepatitis C virus (HCV) antibody, human
immunodeficiency virus (HIV) antibody or Treponema pallidum antibody test was
positive
Pregnant or lactating women or women preparing to be pregnant or lactating during the
study period, or with a positive pregnancy test result at screening stage or baseline
Uncontrollable pericardial effusion, abdominal cavity, pleural effusion and other
third space effusion within 14 days before randomization, and the investigator judges
that they are not suitable for this study
Other circumstances determined by the investigator as unsuitable for participation in
this study
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