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NCT03533127
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
Phase 3 trial testing LY01008 in Non Small Cell Lung Cancer in 648 participants. Status unknown.
28 June 2020
Quick facts
| Lead sponsor | Luye Pharma Group Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 648 |
| Start date | 27 November 2017 |
| Primary completion | 28 June 2020 |
| Estimated completion | 28 December 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- LY01008 — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
- Non Small Cell Lung Cancer Metastatic — all drugs for Non Small Cell Lung Cancer Metastatic →
- Non Small Cell Lung Cancer Recurrent — all drugs for Non Small Cell Lung Cancer Recurrent →
Sponsor
Luye Pharma Group Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Non Small Cell Lung Cancer or Non Small Cell Lung Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 Recurrent Nonsquamous Non-small Cell Lung Cancer
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting Tumor Microenvironment for Cancer Therapy.
Roma-Rodrigues C, Mendes R, Baptista PV, Fernandes AR. · · 2019 · cited 865× · PMID 30781344 · DOI 10.3390/ijms20040840 -
Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy.
Boyero L, Sánchez-Gastaldo A, Alonso M, Noguera-Uclés JF, et al · · 2020 · cited 78× · PMID 33322522 · DOI 10.3390/cancers12123729 -
Current treatments for non-small cell lung cancer.
Guo Q, Liu L, Chen Z, Fan Y, et al · · 2022 · cited 75× · PMID 36033435 · DOI 10.3389/fonc.2022.945102 -
Immunometabolism: new insights and lessons from antigen-directed cellular immune responses.
Ramalho R, Rao M, Zhang C, Agrati C, et al · · 2020 · cited 39× · PMID 32519148 · DOI 10.1007/s00281-020-00798-w -
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.
Shi Y, Lei K, Jia Y, Ni B, et al · · 2021 · cited 20× · PMID 34184418 · DOI 10.1002/cac2.12179 -
Cost-Effectiveness of Bevacizumab Biosimilar LY01008 Combined With Chemotherapy as First-Line Treatment for Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small Cell Lung Cancer.
Luo X, Liu Q, Zhou Z, Yi L, et al · · 2022 · cited 18× · PMID 35517823 · DOI 10.3389/fphar.2022.832215 -
Efficacy and Safety of Bevacizumab Biosimilars Compared With Reference Biologics in Advanced Non-small Cell Lung Cancer or Metastatic Colorectal Cancer Patients: A Network Meta-Analysis.
Xu X, Zhang S, Xu T, Zhan M, et al · · 2022 · cited 8× · PMID 35865968 · DOI 10.3389/fphar.2022.880090 -
Comparison of efficacy and safety of bevacizumab biosimilar and original bevacizumab in non-squamous non-small cell lung cancer: a systematic review and meta-analysis.
Xiao X, Zhang G, Sun B, Wang C, et al · · 2022 · cited 6× · PMID 35836506 · DOI 10.21037/tcr-22-71
Verify or expand the search:
- PubMed search for NCT03533127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LY01008
Trials testing the same drug.
- NCT05110118 — Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male · Phase 1 · completed
Other recruiting trials for Non Small Cell Lung Cancer
Currently open trials in the same condition.
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- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
- NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
- NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
Other Luye Pharma Group Ltd. trials
Trials by the same sponsor.
- NCT07516899 — Mass Balance Study of [14C] LPM3770164 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07391566 — LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation · Phase 1, PHASE2 · not yet recruiting
- NCT07396870 — A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia · Phase 2 · not yet recruiting
- NCT07371065 — To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Sub · Phase 1 · enrolling by invitation
- NCT07230652 — A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT03533127 (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 Luye Pharma Group Ltd.
- Last refreshed: 10 July 2018
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/NCT03533127.
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