Non Small Cell Lung CancerPhase 3NCT03533127

A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

A Phase 3 study testing LY01008 and Bevacizumab in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, run by Luye Pharma Group Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a Randomized, Double-blind, Multicenter Phase III Study Comparing Efficacy and Safety of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Bevacizumab Combined with Paclitaxel and Carboplatin for Treatment of Naïve Subjects with Metastatic or… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
What is being tested?: LY01008 and Bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 648 participants
Where: 1 siteChina
Study dates: 27 Nov 2017to 28 Dec 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

The subject has voluntarily signed the written informed consent form (ICF)
Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive)
The patients with metastatic (stage IV) or recurrent nonsquamous NSCLC proved by histological or cytological demonstrated who cannot have surgical treatment. The diagnosis result of nonsquamous NSCLC obtained only based on the sputum cytology is not accepted. If the patient has many kinds of tumor components, the main cell types should be classified；
The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria)；
The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 1 point.
The predictable survival duration is ≥ 6 months

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Laboratory results during screening:
Blood routine: white blood cell count ≥ 3.0× 109/L, absolute neutrophil count ≥ 1.5× 109/L, platelet count≥ 100× 109/L and hemoglobin≥ 90 g/L.
Liver function: Total bilirubin <1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5×ULN for the subjects without liver metastasis and ALT and AST< 5×ULN for the subjects with liver metastasis.
Kidney function: Serum creatinine ≤ 1.5 ×ULN or creatinine clearance rate ≥ 50 mL/min and urine protein <2+ ( quantitative test for 24h urine protein should be conducted when the baseline urine protein is 2+ and the subject can only be enrolled when the 24 h urine protein quantitation is ≤ 1 g );
The international normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT or aPTT) ≤ 1.5 × ULN within 7 days before the study treatment
The subject can comply with the study protocol.
The female subjects and male subjects of childbearing age and the partners of the male subjects agree to take reliable contraceptive measures (such as abstinence, sterilizing operation, contraceptives, injection of the contraceptive drug medroxyprogesterone acetate or subdermal implant of contraceptives

Who cannot join

The patients who have received chemotherapy or other systemic antineoplastic therapy drugs (such monoclonal antibodies and tyrosine kinase inhibitors) for the disease of the current stage (stage IV or recurrent disease). The patients are allowed to have received past surgery and radiotherapy, but they must meet the criteria for the related two treatment methods listed in the study protocol. The subjects who have recurrented after adjuvant/ neoadjuvant chemotherapy can also be enrolled if the interval between the completion time of the adjuvant/ neoadjuvant therapy and the administration time of the initial dose of the study is more than 6 months；
The subjects with mixed NSCLC which containing small cell cancer component or the squamous-cell carcinoma component dominant；
The patient has history of hemoptysis within 3 months before screening and the expectorated fresh blood is ≥ 2.5 mL.
The images reveal sign of tumor invasion in great vessels. The subjects with tumor completely closes to, surrounds or invades the lumen of great vessels (such as pulmonary artery or superior vena cava) must be excluded;
The subjects with symptomatic brain metastasis, a history of spinal cord compression or meningeal metastases and subjects who have previously received brain metastasis treatment, if their lesion is radiographically confirmed to have remained stable for more than 4 weeks at screening, can be enrolled；
The subjects who have received radical thoracic radiotherapy within 28 days before enrollment and the subjects who have received palliative radiotherapy for the bone lesions besides chest within 2 weeks before the treatment with the first dose of study drugs；

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The subjects who have had major surgery, major trauma (such as fracture) within 28 days before randomization or the subjects who are expected to have major surgery during the study cycle ；
The patients who are taking or have taken aspirin (>325 mg/day) or other non-steroidal anti-inflammatory drugs which are known to be able to inhibit platelet function recently (within 10 days before receiving the initial dose of the study drugs)；
The patients who are taking or have taken whole dose oral or parenteral anticoagulation drugs or thrombolytic agents recently (within 10 days before receiving the initial dose of the study drugs). However, the patients are allowed to have preventive use of anticoagulation drugs；
The patients who have inherited bleeding tendency or coagulation disorders；
The patient with thrombotic diseases which revealed by medical history or examination results within 6 months before enrollment；
The patient with uncontrolled hypertension (systolic pressure is more than 150 mmHg and/or diastolic pressure is more than 100 mmHg), hypertensive crisis or history of hypertensive encephalopathy;
The patient with any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade II), serious arrhythmia，liver, kidney or metabolic diseases that need drug treatment,
The patient with serious unhealed wound and gastrointestinal ulcer. Medical history of the following diseases within 6 months before screening: gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula or intra-abdominal abscess.
The patient with tracheo-esophageal fistula；
The patient with malignant tumors except NSCLC within 5 years before randomization, except the sufficiently treated carcinoma in situ of cervix, basal cell carcinoma or squamous epithelial cancer, local prostate cancer after radical operation, ductal carcinoma in situ after radical operation
The patient with medical history of peripheral neuropathy;
The patient with persistent or active infection signs which need intravenous injection of antibiotics, neurological or metabolic dysfunction, contraindications of the study drugs appear in the physical examination results or laboratory examination results or the patients have signs of suspected diseases or symptoms which result in that the patient has high risk for the treatment related complications；
The patient with hepatitis B surface antigen (HBsAg) positive and the peripheral blood HBV DNA titer ≥1× 103 copies/mL. The subject is eligible to be enrolled if HBsAg is positive and peripheral blood HBV DNA titer <1×103 copies/mL and the investigator considers that the subject is at the stable stage of chronic hepatitis and the risk will not be increased for the subject；
The patient with hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody positive.
The patient has received treatment with any other investigational drugs or has participated in another interventional clinical trial within 30 days before screening
The patient with known allergy to bevacizumab or its any excipient or paclitaxel and carboplatin drug components
The patient has bibulosity within 1 month prior to screening (ie, drinking more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 ml of 40% liquor or 150 mL of wine) or a history of drug abuse；
Pregnant or lactating women or women who prepare to be pregnant or lactate during the study period.
Other circumstances which are considered by the investigator that the subject is unsuitable to be enrolled

Trial locations and contacts

1 site in 1 country.

Can Wu contact

13811253790

wucan@luye.com

China1 site, 1 recruiting

Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, 100021
Yuankai Shi, 8610-87788293, syuankaipumc@126.com
Yuankai Shi
Recruiting

Other trials in China

About this study

Official title: A Phase III Study Comparing Efficacy and Safety of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

Read the detailed description

The objectives are to compare the efficacy, safety and immunogenicity of LY01008 and bevacizumab combined with paclitaxel and carboplatin for treatment of subjects with metastatic or recurrent nonsquamous non-small cell lung cancer.

The subjects will receive the treatment with LY01008 or bevacizumab combined with paclitaxel and carboplatin for 4-6 cycles, and then both groups of subjects will receive the maintenance monotherapy with LY01008 until occurrence of progressive disease (PD), intolerable toxicity reaction, withdrawal of informed consent, loss to follow-up, death, conduct of other antineoplastic therapy or completion of the whole study. The doses of LY01008 and bevacizumab are 15 mg/kg in combination therapy. The dose of LY01008 in maintenance monotherapy is 15 mg/kg.

Conditions: Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
Being tested: LY01008, Bevacizumab
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

LY01008Drug
LY01008+Carboplatin/Paclitaxel
BevacizumabDrug
Bevacizumab + Carboplatin/Paclitaxel

Study groups in NCT03533127
Study group	Role	What they receive
LY01008+Carboplatin/Paclitaxel	Experimental	Drug: LY01008 15 mg/kg IV every 3 weeks on Day 1 Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 175 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles Receives: Drug: LY01008
Bevacizumab + Carboplatin/Paclitaxel	Experimental	Drug: Bevacizumab Bevacizumab 15 mg/kg IV every 3 weeks on Day 1 Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 175 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles Receives: Drug: Bevacizumab

What is being measured

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

Best Objective Response Rate
Measured: 19 weeks from randomization

Secondary outcomes (2)

Progression Free Survival
Measured: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Overall Survival
Measured: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject

Timeline

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

27 Nov 201728 Dec 2020

First posted22 May 2018
Study start27 Nov 2017
Primary completion28 Jun 2020 (estimated)
Study completion28 Dec 2020 (estimated)

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 Non Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
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
Model description: The subjects will receive the treatment with LY01008 or bevacizumab combined with paclitaxel and carboplatin for 4-6 cycles, and then both groups of subjects will receive the maintenance monotherapy with LY01008
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 648 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03533127
Sponsor's protocol ID: LY01008
Status last verified: Jul 2018
First submitted: 10 May 2018
Last updated: 10 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Shi Y, Lei K, Jia Y, Ni B, He Z, Bi M, Wang X, Shi J, Zhou M, Sun Q, Wang G, Chen D, Shu Y, Liu L, Guo Z, Liu Y, Yang J, Wang K, Xiao K, Wu L, Yi T, Sun D, Kang M, Ma T, Mao Y, Shi J, Tang T, Wang Y, Xing P, Lv D, Liao W, Luo Z, Wang B, Wu X, Zhu X, Han S, Guo Q, Liu R, Lu Z, Zhang J, Fang J, Hu C, Ji Y, Liu G, Lu H, Wu D, Zhang J, Zhu S, Liu Z, Qiu W, Ye F, Yu Y, Zhao Y, Zheng Q, Chen J, Pan Z, Zhang Y, Lian W, Jiang B, Qiu B, Zhang G, Zhang H, Chen Y, Chen Y, Duan H, Li M, Liu S, Ma L, Pan H, Yuan X, Yuan X, Zheng Y, Gao E, Zhao L, Wang S, Wu C. Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial. Cancer Commun (Lond). 2021 Sep;41(9):889-903. doi: 10.1002/cac2.12179. Epub 2021 Jun 29.
PubMed 34184418

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study Comparing Efficacy and Safety of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT03533127
Acronym / sponsor ID: LY01008
Conditions: Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 648 participants (estimated)
Lead sponsor: Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
Study start: 27 Nov 2017 (actual)
Primary completion: 28 Jun 2020 (estimated)
Study completion: 28 Dec 2020 (estimated)
First posted: 22 May 2018 (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: Double blind (participant, investigator)
Number of arms: 2
Model description: The subjects will receive the treatment with LY01008 or bevacizumab combined with paclitaxel and carboplatin for 4-6 cycles, and then both groups of subjects will receive the maintenance monotherapy with LY01008

Arm	Type	Receives
LY01008+Carboplatin/Paclitaxel	Experimental	Drug: LY01008Drug: LY01008 15 mg/kg IV every 3 weeks on Day 1 Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 175 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Bevacizumab + Carboplatin/Paclitaxel	Experimental	Drug: BevacizumabDrug: Bevacizumab Bevacizumab 15 mg/kg IV every 3 weeks on Day 1 Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 175 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Who may qualify

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

Key inclusion criteria (13 listed)

The subject has voluntarily signed the written informed consent form (ICF)
Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive)
The patients with metastatic (stage IV) or recurrent nonsquamous NSCLC proved by histological or cytological demonstrated who cannot have surgical treatment. The diagnosis result of nonsquamous NSCLC obtained only based on the sputum cytology is not accepted. If the patient has many kinds of tumor components, the main cell types should be classified；
The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria)；
The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 1 point.

Key exclusion criteria (25 listed)

The patients who have received chemotherapy or other systemic antineoplastic therapy drugs (such monoclonal antibodies and tyrosine kinase inhibitors) for the disease of the current stage (stage IV or recurrent disease). The patients are allowed to have received past surgery and radiotherapy, but they must meet the criteria for the related two treatment methods listed in the study protocol. The subjects who have recurrented after adjuvant/ neoadjuvant chemotherapy can also be enrolled if the interval between the completion time of the adjuvant/ neoadjuvant therapy and the administration time of the initial dose of the study is more than 6 months；
The subjects with mixed NSCLC which containing small cell cancer component or the squamous-cell carcinoma component dominant；
The patient has history of hemoptysis within 3 months before screening and the expectorated fresh blood is ≥ 2.5 mL.
The images reveal sign of tumor invasion in great vessels. The subjects with tumor completely closes to, surrounds or invades the lumen of great vessels (such as pulmonary artery or superior vena cava) must be excluded;
The subjects with symptomatic brain metastasis, a history of spinal cord compression or meningeal metastases and subjects who have previously received brain metastasis treatment, if their lesion is radiographically confirmed to have remained stable for more than 4 weeks at screening, can be enrolled；

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
LY01008LY01008+Carboplatin/Paclitaxel	Drug	LY01008+Carboplatin/Paclitaxel
BevacizumabBevacizumab + Carboplatin/Paclitaxel	Drug	Bevacizumab + Carboplatin/Paclitaxel

Primary outcome

Best Objective Response Rate
Time frame: 19 weeks from randomization

2 secondary outcomes

Progression Free Survival
Time frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Overall Survival
Time frame: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
Derived from this study: PubMed 34184418Shi Y, Lei K, Jia Y, Ni B, He Z, Bi M, Wang X, Shi J, Zhou M, Sun Q, Wang G, Chen D, Shu Y, Liu L, Guo Z, Liu Y, Yang J, Wang K, Xiao K, Wu L, Yi T, Sun D, Kang M, Ma T, Mao Y, Shi J, Tang T, Wang Y, Xing P, Lv D, Liao W, Luo Z, Wang B, Wu X, Zhu X, Han S, Guo Q, Liu R, Lu Z, Zhang J, Fang J, Hu C, Ji Y, Liu G, Lu H, Wu D, Zhang J, Zhu S, Liu Z, Qiu W, Ye F, Yu Y, Zhao Y, Zheng Q, Chen J, Pan Z, Zhang Y, Lian W, Jiang B, Qiu B, Zhang G, Zhang H, Chen Y, Chen Y, Duan H, Li M, Liu S, Ma L, Pan H, Yuan X, Yuan X, Zheng Y, Gao E, Zhao L, Wang S, Wu C. Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial. Cancer Commun (Lond). 2021 Sep;41(9):889-903. doi: 10.1002/cac2.12179. Epub 2021 Jun 29.
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.

Can Wu contact

13811253790

wucan@luye.com

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 LY01008 and Bevacizumab in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, run by Luye Pharma Group 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 13 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 10 Jul 2018. 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?

Results are not available in the source record.

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

Contact Can Wu (13811253790, wucan@luye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Objective Response Rate (time frame: 19 weeks from randomization). 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 NCT03533127, 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 10 Jul 2018.