TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer

NCT05427305 | Completed Phase 3

• 1 other identifier: TOT-CR-TAB008-Ⅲ-01
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized, double-blind, multicenter, phase III similarity study, treatment naive, EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (ns-NSCLC) patients were enrolled and randomized (1:1) into TAB008 or Bevacizumab-EU groups. Patients received TAB008 or bevacizumab-EU 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles followed by TAB008 or bevacizumab-EU 7.5 mg/kg until disease progression, unacceptable toxicity or death. The primary endpoint compared the objective response rate (ORR) within 6 cycles as read by an independent radiological review committee (IRRC). Secondary endpoints compared disease control rate (DCR) Within 6 cycles, duration of response (DoR), progression free survival (PFS), a year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and steady state pharmacokinetics.

Conditions

Efficacy

Outcome Measures

Primary Outcomes (1)

• ORR

  The primary endpoint is overall response rate (ORR) within the first 6 cycles of treatment.ORR includes Complete Response Rate and Partial Response Rate.ORR will be independently evaluated by the independent radiology review committee (IRRC).

  at the end of cycle 6 (each cycle is 21 days).

Secondary Outcomes (5)

• Disease control rate(DCR)

  at the end of cycle 6 (each cycle is 21 days).

• Duration of Response (DoR)

  the time from the date of first documented response (CR or PR) until the first date of documented progression or death, and any participant not known to have died at the time of analysis were censored based on the last objective tumor evaluation.

• PFS

  From the date of randomization until the date of objective disease progression or death

• overall survival rate(OSR) at 12 months

  12 months after date of randomization

• Overall survival(OS)

  From the time from the date of randomization until death due to any cause, assessed up to the data cut-off date.

Study Arms (2)

TAB008

EXPERIMENTAL

Eligible patients received TAB008 15 mg/kg every three weeks for 6 cycles, then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death.

Drug: TAB008

Bevacizumab

ACTIVE COMPARATOR

Eligible patients received bevacizumab-EU 15 mg/kg every three weeks for 6 cycles, then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death.

Drug: Bevacizumab

Interventions

TAB008 DRUG

15 mg/kg every three weeks for 6 cycles,then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death

TAB008

Bevacizumab DRUG

15 mg/kg every three weeks for 6 cycles,then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death

Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily participate in the study and sign the informed consent form;
• Aged 18 to 75 years (inclusive), male or female;
• Patients with histologically and/or cytologically confirmed, inoperable, locally advanced (Stage IIIb, IIIc), metastatic (Stage IV), or relapsed or progressive non-squamous cell carcinoma after local therapy (in cases of multiple tumor components, the predominant cell type is classified);
• No sensitive mutation of epidermal growth factor receptor (EGFR) gene (18, 19, 21), no other known activating mutations (such as ALK, ROS) which has treatment approved by NMPA;
• At least one measurable lesion according to RECIST 1.1 criteria; and this lesion has not received radiotherapy:
• Definition of measurable disease: Lesions that can be precisely measured in at least one dimension by any of the following: computed tomography (CT) scan or magnetic resonance imaging (MRI) scan with enhanced spiral CT or multidetector CT (MDCT) with extra-nodal lesions at least 10 mm in diameter and lymph node lesions at least 15 mm in short axis when the slice thickness is 5 mm or less；
• Patients who have never received systemic chemotherapy, anti-angiogenic drug and molecular targeted drug therapy for primary tumor or metastasis (note: subjects who received adjuvant therapy previously are allowed, but only patients who have no progression or recurrence during and within 6 months after completion of adjuvant therapy)；
• ≤ ECOG PS ≤ 1;
• Expected survival time ≥ 3 months;
• The subject has recovered from the damage caused by other local treatments, including radiotherapy or surgery \> 4 weeks from the start of study treatment, and the wound has completely healed; however, patients who receive palliative radiotherapy for bone metastases 2 weeks before the start of study treatment can be allowed;
• Laboratory tests within 14 days before randomization meet the requirements.

You may not qualify if:

• Patients with brain metastases ;
• History of bleeding diathesis, high risk of bleeding, or coagulopathy, including thrombotic disease within 6 months prior to Screening and/or hemoptysis (≥ 2.5 mL in a single cough) within 3 months prior to Screening;
• CT/MRI image shows tumor encasement or invasion into the lumen of great vessels (e.g., pulmonary artery or superior vena cava) and patients with bleeding risk judged by the investigator;
• Uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg after combination therapy with two or more antihypertensive agents), and patients with a previous history of hypertensive crisis or hypertensive brain;
• Significant cardiovascular or cerebrovascular disease;
• Active peptic ulcer or fracture, active infection at randomization, tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intra-abdominal abscess within 6 months before screening;
• Patients who have undergone major surgical procedures (including open-heart biopsy), have major trauma, or are expected to require major surgery during the study;
• Minor surgical procedures (e.g., deep veins, ports) within 24 hours prior to receiving study drug;
• Moderate to large amount of pericardial effusion, abdominal or pleural effusion that cannot be controlled by pumping or other symptomatic treatment (symptomatic treatment is allowed, but drugs with anti-tumor indications such as chemotherapeutic drugs, anti-angiogenic drugs and molecular targeted drugs cannot be given);
• Known hypersensitivity to bevacizumab, paclitaxel and carboplatin injection and its excipients;
• Patients with other malignant tumors except lung cancer within 5 years;
• Patients who have used other clinical study treatment within 4 weeks before the start of study treatment;
• History of alcohol or drug abuse;
• Pregnant and lactating women; women of childbearing potential and male patients who require effective contraceptive methods during the study and for 6 months after administration of study drug;
• Other conditions that, in the opinion of the investigator, should not be included.

Sponsors & Collaborators

• BioDlink Biopharm Co., Ltd.: lead

Study Sites (1)

TOT

Suzhou, Jiangsu, 215024, China

Location

Related Publications (1)

• Lu S, Qin S, Zhou Z, Chen J, Gu K, Sun P, Pan Y, Yu G, Ma K, Shi J, Sun Y, Yang L, Chen P, Liu A, He J. Bevacizumab biosimilar candidate TAB008 compared to Avastin(R) in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study. J Cancer Res Clin Oncol. 2023 Aug;149(9):5907-5914. doi: 10.1007/s00432-022-04563-4. Epub 2023 Jan 3.

  PMID: 36595042 DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• min liu, doctor

  No120changyang street ,Suzhou Industrial Park, Jiangsu

  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

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 22, 2022
• Study Start: October 20, 2017
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)