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Non-squamous Cell Non-small Cell Lung CancerPhase 3NCT03792074

To Evaluate the Efficacy and Safety of SCT510 in the Treatment of Non-small Cell Lung Cancer

A Phase 3 study testing SCT510, Bevacizumab and Paclitaxel in people with Non-squamous Cell Non-small Cell Lung Cancer, run by Sinocelltech Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
SCT510, Bevacizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
No sites listed yet
Study dates
Feb 2019to Jan 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in this study and sign the informed consent;
  • age is ≤ 18 years old and ≥ 80 years old, regardless of gender;
  • Subjects with unresectable locally advanced metastatic(Not suitable for the multidisciplinary treatment Ⅲ B - Ⅳ period of subjects, according to the international association for the study of lung cancer (IASLC) lung cancer staging manual version 8 standard judgment) or recurrent non-squamous cell non-small cell lung cancer diagnosed by histological and/or cytological examination.The diagnosis of non-squamous cell non-small cell lung cancer based on sputum cytology requires immunohistochemical confirmation.If multiple tumor components are mixed, the main cell types are classified.
  • It is able to provide relevant documents about EGFR mutation and ALK fusion gene status, and there is no EGFR sensitive mutation (including exon mutation no. 18 (G719X), exon deletion no. 19 and exon mutation no. 21 (L858R, L861Q)) and ALK fusion.Subjects who have not previously undergone EGFR and ALK gene testing will need to undergo genetic testing during the screening period.Among them, subjects whose EGFR or ALK gene status cannot be determined for various reasons can be enrolled;Subjects who are known to have EGFR sensitive mutations and/or ALK fusion may also be enrolled if they are currently unable to obtain the corresponding targeted drugs (including the rejection of the subjects) and chemotherapy is standard treatment at the research center;
  • According to RECIST v1.1 criteria, at least one measurable lesion was ensured;The lesions that had received radiotherapy before could only be selected as target lesions if there was clear disease progression 3 months after the end of radiotherapy.
  • Systemic antitumor therapy for locally advanced metastatic or recurrent non-squamous non-small cell lung cancer has not been accepted.If the subjects in the complete early non-small cell lung cancer after radical treatment received adjuvant therapy, and disease relapse, participants need to ensure that adjuvant therapy over time from this study first dosing interval more than 6 months, and auxiliary treatment led to a variety of toxic effects have been restored (according to the CTCAE v4.03 standard judgment level 1 or less, except for hair loss).
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  • Eastern Cooperative Oncology Group (ECOG) physical condition score 0 or 1
  • the expected survival time is more than 6 months;
  • Laboratory inspection meets the following requirements:
  • absolute neutrophil value (ANC) is greater than 1.5 x 109/L, platelet count (PLT) is greater than 100 x 109/L, hemoglobin (HGB) is greater than 90 g/L, and white blood cell (WBC) is greater than 3.0 x 109/L;
  • liver function: total bilirubin (TBil) < 1.5 times the normal upper limit; Aspartate aminotransferase(AST/SGOT),Alanine aminotransferase (ALT/SGPT),andalkaline phosphatase(ALP) < 2.5 times the normal upper limit;In the case of liver metastasis, AST and ALT were less than or equal to 5.0 times the upper limit of normal values.In the case of liver metastasis and/or bone metastasis, ALP is less than or equal to 5.0 times the normal upper limit.
  • renal function: upper limit of normal serum creatinine (Scr) less than 1.5 times;
  • urine protein < 2 (+) detected by routine urine test;If the urine protein at baseline is greater than or equal to 2 (+), the 24-hour urine protein quantification must be less than or equal to 1.0 g.
  • coagulation function: the international standardized ratio (INR) is no more than 1.5, and the activation time of partial thrombin (APTT) is no more than 1.5 times the upper limit of normal value;
  • Heart function: left ventricular ejection fraction (LVEF) 50% or higher;
  • able to communicate well with researchers and follow the visit, treatment, laboratory examination and other relevant regulations stipulated in the study.

Who cannot join

  • subjects with mixed non-small cell and small cell carcinoma, squamous cell carcinoma or mixed adenosquamous carcinoma with squamous cell as the main component
  • patients with a history of tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intraperitoneal abscess within 6 months before randomization;
  • patients with malignant tumors other than lung cancer within the first 5 years were randomized, excluding cured carcinoma in situ of the cervix, skin basal cells cancer or squamous epithelial cells skin cancer, local prostate cancer after radical resection and ductal carcinoma in situ of the breast after radical resection;
  • severe cardiovascular and cerebrovascular diseases, including cerebrovascular accidents (CVA), transient ischemic attack (TIA), myocardial infarction and significant vascular diseases (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis) within the first 6 months randomly;Patients with unstable angina, New York heart association (NYHA) classification ≥ Ⅱ heart failure and arrhythmia drugs can't control;
  • Subjects who received lung radiotherapy within the first 4 weeks or who had not recovered from radiation-related toxicity were randomized.For all other anatomical sites, subjects received radiotherapy within the first 2 weeks of randomization or did not recover from radiation-related toxicity;
  • Major surgery was performed within the first 4 weeks of randomization or major surgical treatment was planned during the trial period (the researchers determined that there was a risk of bleeding or wound healing complications);
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  • Have bleeding tendency, high bleeding risk or coagulation dysfunction, including thrombotic disease within 6 months prior to randomization and/or hemoptysis history within 3 months prior to randomization (single hemoptysis is more than 2.5mL);Or recently (less than 10 days after the first study drug treatment) using a full dose oral or extralimental anticoagulant or thrombolytic agent or aspirin (> 325 mg/ day) or other nsaids that inhibit platelet function;Or prior to surgery, the researchers determined that there was a tendency to bleed;
  • subjects with high suspicion of idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia or active pneumonia in chest CT scan during the screening period;
  • subjects with known central nervous system metastasis (except asymptomatic brain metastasis and subjects with treated symptoms controlled and stable symptoms within 1 month prior to randomization).Patients with clinical suspected central nervous system metastasis must undergo enhanced CT or MRI within the first 28 days randomly to exclude central nervous system metastasis.
  • imaging examination showed signs of tumor invasion into the large blood vessel, and the tumor had completely approached, wrapped or invaded the large blood vessel cavity (such as pulmonary artery or superior vena cava);
  • patients with hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) who are still under poor control after combined treatment with two or more antihypertensive drugs in the screening period, as well as those who have a history of hypertension crisis or hypertensive encephalosis;
  • The presence of unhealed wounds, active peptic ulcers and fractures (excluding healed old fractures);
  • There is a large amount of pericardial effusion, peritoneal or pleural effusion that cannot be controlled by drainage or other symptomatic treatment (symptomatic treatment is allowed before enrollment, but drugs with anti-tumor indications, such as chemotherapy drugs, anti-angiogenic drugs and molecular targeted drugs, cannot be given);
  • HBsAg is positive, and the titer detection of HBV-DNA in peripheral blood ≥ 1x103 copy number /mL (or the quantitative determination of HBV-DNA ≥200 units /mL); HCV or HIV or syphilis positive subjects;At present, there are other active infectious diseases, which are not suitable for inclusion in this study.
  • known for SCT510, bevacizumab, paclitaxel and carboplatin injection and its material composition allergies;
  • women who are pregnant or breast-feeding;
  • women of child-bearing age or male subjects who are unwilling to take effective contraceptive measures during the study period or within 6 months after the last administration of the study drugs;
  • subjects who have participated in other clinical studies in the first 4 weeks of randomization or who are receiving treatment in other clinical trials (except those who participated in the overall survival follow-up of one study);
  • previous history of alcoholism or drug abuse;
  • in addition to the above circumstances, the researcher believes that there are other circumstances that are not suitable for inclusion.

Trial locations and contacts

No sites are listed yet.

About this study

Official title: to Evaluate SCT510 Compared to Avasitin Respectively Combined Paclitaxel and Carboplatin First-line Treatment of Locally Advanced and Metastatic or Recurrent Squamous Cell Non-small Cell Lung Cancer Efficacy and Safety

To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell lung cancer.

Read the detailed description

A randomized, double-blind, parallel-controlled, multicenter phase 3 clinical trial.

560 patients with non-resectable locally advanced, metastatic or recurrent non-squamous cell non-small cell lung cancer (NSCLC) were randomly divided into two groups (SCT510 group and bevacizumab group) at a 1:1 ratio, and the treatment included combination chemotherapy and maintenance treatment, followed by follow-up.

Being tested
SCT510, Bevacizumab, Paclitaxel, Carboplatin

What participants receive

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

  • SCT510Drug

    SCT510 Injection

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab Injection

  • PaclitaxelDrug

    Also called PTX;TAX

    Paclitaxel Injection

  • CarboplatinDrug

    Carboplatin injection

Study groups in NCT03792074
Study groupRoleWhat they receive
SCT510 combined paclitaxel and carboplatinExperimentalSCT510 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion,on day 1,Once every 3 weeks;Four to six cycles in a row
Receives: Drug: SCT510; Drug: Paclitaxel; Drug: Carboplatin
Bevacizumab combined paclitaxel and carboplatinActive comparatorBevacizumab 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion,on day 1,Once every 3 weeks;Four to six cycles in a row
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Objective response rate

    the proportion of subjects whose CR(complete response) and PR(partial response)combined , according to RECIST 1.1 criteria

    Measured: 12 weeks

Secondary outcomes (6)
  1. Objective response rate

    the proportion of subjects whose CR(complete response) and PR(partial response)combined , according to RECIST 1.1 criteria

    Measured: 18 week

  2. Disease control rate

    the proportion of subjects with CR(complete response), PR(partial response) and SD(Stable disease) combined,according to RECIST 1.1 criteria

    Measured: 12 weeks and 18 weeks

  3. Duration of Response

    The time from the first assessment of CR(complete response) or PR(partial response) to the first assessment of PD(progressive disease) or any cause of death,according to RECIST 1.1 criteria

    Measured: 3 years

  4. Progression free survival

    The time from randomization to PD(progressive disease) or any cause of death,according to RECIST 1.1 criteria

    Measured: 3 years

  5. 1-year overall survival rate

    The proportion of subjects who survived longer than 1 year after randomization

    Measured: 1 year

  6. Overall survival

    Defined as the time from randomization of subjects to death from any cause

    Measured: 3 years

Timeline

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

  1. First posted3 Jan 2019
  2. Study startFeb 2019 (estimated)
  3. Primary completionMay 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

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
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03792074
Sponsor's protocol ID
SCT510-A301
Status last verified
Dec 2018
First submitted
26 Dec 2018
Last updated
3 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hong Q, Jiao Y, Li D, Ma H, Wu K, Xie L. Population Pharmacokinetics of SCT510 (a Bevacizumab Biosimilar) and Avastin(R) in Healthy Subjects and Patients with Non-squamous Non-small Cell Lung Cancer. Clin Drug Investig. 2026 Feb;46(2):143-157. doi: 10.1007/s40261-025-01518-8. Epub 2026 Jan 6.

    PubMed 41495391
  • Cheng Y, Pan Z, Wu L, Zhu B, Yu Y, Zang K, Zhuang W, Liu L, Gu K, Lian J, Chen R, Bian T, Lin D, Sun S, Li W, Hang X, Jiang O, Zhong F, Wang R, Luo H, Shi H, Wei Z, Zhao L, Chen S, Sun H, Li X, Sun D, Ren T, Lei K, He M, Li G, Liu H, Li R, Hu C, Kong L, Sun M, Xie L, Gai W, Chen W, Huang Z, Ren W, Su H. Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study. Adv Ther. 2024 Nov;41(11):4032-4048. doi: 10.1007/s12325-024-02965-z. Epub 2024 Sep 4.

    PubMed 39230871

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCT510, Bevacizumab and Paclitaxel in people with Non-squamous Cell Non-small Cell Lung Cancer, run by Sinocelltech Ltd..

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 16 inclusion and 20 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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 ming gao (8618610163675, ming_gao@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 12 weeks). 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 NCT03792074, which also lists 2 linked publications.

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 3 Jan 2019.

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