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

NCT05318443 | Completed Phase 3

• 1 other identifier: SIBP04-02
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-squamous Non-small-cell Lung Cancer

Keywords

Non-squamous Non-small-cell Lung Cancer; Efficacy; Safety; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the best ORR from the first medication to the 18th week, initially evaluated by the investigator, and finally evaluated by a third-party independent blinded imaging, including cases of complete response (CR) and partial response (PR).

  up to 18th week.

Secondary Outcomes (4)

• Progression-free survival(PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 weeks.

• Overall survival (OS)

  From date of randomization until the date of event-occurring or last visit, assessed up to 30 weeks.

• Duration of response (DOR)

  From date of the first evaluation of a tumor as CR or PR until the date of the first evaluation of a patient's state as disease progression or death, assessed up to 30 weeks.

• Disease control rate (DCR)

  up to 18th week.

Other Outcomes (6)

• The number of adverse events (AE)

  The last 1 day of 18th weeks after randomization.

• The number of serious adverse events (SAE)

  The last 1 day of 30th weeks after randomization.

• The incidence of anti-drug antibodies(ADAs)

  The last 1 day of 18th weeks after randomization.

Study Arms (2)

Experimental

EXPERIMENTAL

SIBP04 \& Paclitaxel \& Carboplatin

Drug: SIBP04; Drug: Paclitaxel; Drug: Carboplatin

Control group

ACTIVE COMPARATOR

Avastin \& Paclitaxel \& Carboplatin

Drug: Avastin; Drug: Paclitaxel; Drug: Carboplatin

Interventions

SIBP04 DRUG

SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.

Experimental

Avastin DRUG

Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.

Control group

Paclitaxel DRUG

Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.

Control group; Experimental

Carboplatin DRUG

Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.

Control group; Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 5×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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• Shi Y, Bi M, Li Q, Wang G, Chen J, Li M, Shi J, Mei J, Ji Y, Xia Q, Feng Y, Xu S, Zhang T, Gao X, Tang S, Weng J, Cao Z, Wu H, Ren X, Xie H, Liu H, Liu Q, Yin X, Luo X, Chen J, Zhang H, Guo Z, Ding C, Jin X, Sun R, Yang S. Efficacy and safety of bevacizumab biosimilar SIBP04 compared with bevacizumab (Avastin(R)) as first-line treatment for locally advanced or metastatic non-squamous non-small-cell lung cancer: A randomized, double-blind, phase 3 trial. Cancer Pathog Ther. 2025 Jan 6;3(4):337-345. doi: 10.1016/j.cpt.2025.01.001. eCollection 2025 Jul.

  PMID: 40697509 DERIVED

• Qu A, Zhang S, Zou H, Li S, Chen D, Zhang Y, Li S, Zhang H, Yang J, Yang Y, Huang Y, Li X, Zhang Y. Outcome benefits of bevacizumab biosimilar (SIBP04) combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer patients with EGFR mutation: subgroup analysis of a prospective, randomized phase III clinical trial. J Cancer Res Clin Oncol. 2023 Nov;149(14):12713-12721. doi: 10.1007/s00432-023-05103-4. Epub 2023 Jul 15.

  PMID: 37452849 DERIVED

MeSH Terms

Interventions

Bevacizumab; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Yuankai Shi, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Aidong Qu, Master

  Co., Ltd Shanghai Institute Of Biological Products

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, parallel-controlled, multicenter Phase III clinical study.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: April 17, 2020
• Primary Completion: December 26, 2022
• Study Completion: January 12, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)