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

NCT03792074 | Unknown Phase 3

• 1 other identifier: SCT510-A301
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-squamous Cell Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

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

  12 weeks

Secondary Outcomes (6)

• Objective response rate

  18 week

• Disease control rate

  12 weeks and 18 weeks

• Duration of Response

  3 years

• Progression free survival

  3 years

• 1-year overall survival rate

  1 year

Study Arms (2)

SCT510 combined paclitaxel and carboplatin

EXPERIMENTAL

SCT510 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row

Drug: SCT510; Drug: Paclitaxel; Drug: Carboplatin

Bevacizumab combined paclitaxel and carboplatin

ACTIVE COMPARATOR

Bevacizumab 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row

Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

SCT510 DRUG

SCT510 Injection

SCT510 combined paclitaxel and carboplatin

Bevacizumab DRUG

Bevacizumab Injection

Also known as: Avastin

Bevacizumab combined paclitaxel and carboplatin

Paclitaxel DRUG

Paclitaxel Injection

Also known as: PTX;TAX

Bevacizumab combined paclitaxel and carboplatin; SCT510 combined paclitaxel and carboplatin

Carboplatin DRUG

Carboplatin injection

Bevacizumab combined paclitaxel and carboplatin; SCT510 combined paclitaxel and carboplatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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;

You may not qualify if:

• 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);
• 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);
• known for SCT510, bevacizumab, paclitaxel and carboplatin injection and its material composition allergies;
• women who are pregnant or breast-feeding;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Related Publications (2)

• 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 Jan 6. doi: 10.1007/s40261-025-01518-8. Online ahead of print.

  PMID: 41495391 DERIVED

• 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.

  PMID: 39230871 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

Central Study Contacts

ming gao

CONTACT

8618610163675; ming_gao@sinocelltech.com

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: December 26, 2018
• First Posted: January 3, 2019
• Study Start: February 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 3, 2019

Record last verified: 2018-12