NCT05318443 is a Phase 3 clinical trial of SIBP04 in Non-squamous Non-small-cell Lung Cancer, sponsored by Shanghai Institute Of Biological Products.

Who is sponsoring NCT05318443?

NCT05318443 is sponsored by Shanghai Institute Of Biological Products.

What drugs are being tested in NCT05318443?

Interventions in NCT05318443: SIBP04, Avastin, Paclitaxel, Carboplatin.

What condition does NCT05318443 study?

NCT05318443 studies Non-squamous Non-small-cell Lung Cancer.

Is NCT05318443 still recruiting?

NCT05318443 is currently completed. Last updated 27 December 2023.

Last reviewed 2023-12-27 · How we verify

NCT05318443

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer

Completed Phase 3 Last updated 27 December 2023

What this trial tests

Phase 3 trial testing SIBP04 in Non-squamous Non-small-cell Lung Cancer in 512 participants. Completed in 12 January 2023.

Timeline

17 April 2020

Primary endpoint
26 December 2022

12 January 2023

Quick facts

Lead sponsor	Shanghai Institute Of Biological Products
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	512
Start date	17 April 2020
Primary completion	26 December 2022
Estimated completion	12 January 2023
Sites	1 location across China

Drugs / interventions tested

SIBP04
Avastin — full drug profile →
Paclitaxel — full drug profile →
Carboplatin (Carboplatin) — full drug profile →

Conditions studied

Non-squamous Non-small-cell Lung Cancer — all drugs for Non-squamous Non-small-cell Lung Cancer →

Sponsor

Shanghai Institute Of Biological Products

Who can join

Adults 18 to 75, any sex, with Non-squamous Non-small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Trial watch: chemotherapy-induced immunogenic cell death in oncology.
Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591
The mechanistic immunosuppressive role of the tumour vasculature and potential nanoparticle-mediated therapeutic strategies.
Ileiwat ZE, Tabish TA, Zinovkin DA, Yuzugulen J, et al · · 2022 · cited 7× · PMID 36045675 · DOI 10.3389/fimmu.2022.976677
Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115
Efficacy and safety of bevacizumab biosimilar SIBP04 compared with bevacizumab (Avastin®) as first-line treatment for locally advanced or metastatic non-squamous non-small-cell lung cancer: A randomized, double-blind, phase 3 trial.
Shi Y, Bi M, Li Q, Wang G, et al · · 2025 · cited 2× · PMID 40697509 · DOI 10.1016/j.cpt.2025.01.001
Outcome benefits of bevacizumab biosimilar (SIBP04) combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer patients with EGFR mutation: subgroup analysis of a prospective, randomized phase III clinical trial.
Qu A, Zhang S, Zou H, Li S, et al · · 2023 · PMID 37452849 · DOI 10.1007/s00432-023-05103-4

Verify or expand the search:

Other recruiting trials for Non-squamous Non-small-cell Lung Cancer

Currently open trials in the same condition.

NCT05403554 — A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers · Phase 1 · recruiting

Other Shanghai Institute Of Biological Products trials

Trials by the same sponsor.

NCT07363837 — Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants · Phase 1, PHASE2 · not yet recruiting
NCT07327398 — Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 2 · not yet recruiting
NCT07253675 — Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo · Phase 2 · not yet recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07205198 — A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects. · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05318443 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Institute Of Biological Products
Last refreshed: 27 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05318443.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing