EfficacyPhase 3NCT05427305

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

A Phase 3 study testing TAB008 and Bevacizumab in people with Efficacy, run by BioDlink Biopharm Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Efficacy
What is being tested?: TAB008 and Bevacizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 549 participants
Where: 1 siteChina
Study dates: 20 Oct 2017to 24 Mar 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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；

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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)；
0 ≤ 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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

TOT
Suzhou, Jiangsu, 215024

Other trials in China

About this study

Official title: Bevacizumab Biosimilar Candidate TAB008 Compared to Avastin® in Patients With Locally Advanced, Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer: a Randomized, Double-blind, Multicenter Study

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.

Read the detailed description

This randomized, double-blind, equivalence study was conducted in China. Treatment naïve, EGFR wild-type (by PCR or NGS) nsNSCLC patients were enrolled. Patients had to be between 18-75 years of age; stage IIIB to IV pathology confirmed nsNSCLC; ECOG PS 0-1; have adequate organ function; no uncontrollable infectious or serious illnesses; and most importantly, measurable lesion according to Response Evaluation Criteria in Solid Tumor(RECIST) version 1.1. Major exclusion criteria included tumors invading major blood vessels, previous major cardiovascular accidents (stroke, heart attack, uncontrollable hypertension), bleeding diathesis, proteinuria; prior history of malignancy other than NSCLC. Patients underwent tumor assessment using contrast-enhanced CT scans every two cycles for the first six cycles, then every four cycles thereafter until disease progression. Eligible patients were randomized 1:1 to receive TAB008 or 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. All patients received carboplatin (area under the curve (AUC)=5.0 mg/ml/min) and paclitaxel (175 mg/m2) every three weeks for between 4 to 6 cycles.Eligible subjects were randomized 1:1 by the Interactive Web Response System (IWRS) into the TAB008 group or bevacizumab-EU group.The primary endpoint would be overall response rate (ORR) within the first 6 cycles of treatment determined by the independent radiology review committee (IRRC).

Conditions: Efficacy
Being tested: TAB008, Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAB008Drug
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
BevacizumabDrug
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

Study groups in NCT05427305
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Disease control rate(DCR)
Disease Control Rate is defined as the proportion of patients with complete response(CR), partial response(PR), or stable disease(SD) as defined by RECIST 1.1.
Measured: at the end of cycle 6 (each cycle is 21 days).
Duration of Response (DoR)
DoR was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression .
Measured: 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
PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).
Measured: From the date of randomization until the date of objective disease progression or death
overall survival rate(OSR) at 12 months
12-month OSR was defined as the proportion of patients who have not died at 12 months after randomization over the total number of evaluable patients.
Measured: 12 months after date of randomization
Overall survival(OS)
The OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive.
Measured: From the time from the date of randomization until death due to any cause, assessed up to the data cut-off date.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 201724 Mar 2020

First posted22 Jun 2022
Study start20 Oct 2017
Primary completion24 Mar 2020
Study completion24 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EfficacyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 549 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05427305
Sponsor's protocol ID: TOT-CR-TAB008-Ⅲ-01
Status last verified: Jun 2022
First submitted: 9 Jun 2022
Last updated: 22 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36595042

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bevacizumab Biosimilar Candidate TAB008 Compared to Avastin® in Patients With Locally Advanced, Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer: a Randomized, Double-blind, Multicenter Study
ClinicalTrials.gov ID: NCT05427305
Acronym / sponsor ID: TOT-CR-TAB008-Ⅲ-01
Conditions: Efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 549 participants (actual)
Lead sponsor: BioDlink Biopharm Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Oct 2017 (actual)
Primary completion: 24 Mar 2020 (actual)
Study completion: 24 Mar 2020 (actual)
First posted: 22 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TAB008	Experimental	Drug: TAB008Eligible 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.
Bevacizumab	Active comparator	Drug: BevacizumabEligible 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAB00815 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
Bevacizumab15 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

Primary outcome

ORR
Time frame: at the end of cycle 6 (each cycle is 21 days).
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).

5 secondary outcomes

Disease control rate(DCR)
Time frame: at the end of cycle 6 (each cycle is 21 days).
Duration of Response (DoR)
Time frame: 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
Time frame: From the date of randomization until the date of objective disease progression or death
overall survival rate(OSR) at 12 months
Time frame: 12 months after date of randomization
Overall survival(OS)
Time frame: From the time from the date of randomization until death due to any cause, assessed up to the data cut-off date.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Derived from this study: PubMed 36595042Lu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

min liu, doctor study director

No120changyang street ,Suzhou Industrial Park, Jiangsu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAB008 and Bevacizumab in people with Efficacy, run by BioDlink Biopharm Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: at the end of cycle 6 (each cycle is 21 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05427305, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.