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Peer-reviewedCC BYMedComm

Efficacy and Safety of Lucitanib in Advanced Thymic Carcinoma: A Randomized Phase II Trial.

  • Wentao Fang1
  • Caicun Zhou2
  • Changlu Wang3
  • Kailiang Wu4
  • Jianhua Fu5
  • Xiaoyan Lin6
  • Helong Zhang7
  • Jianhua Chen8
  • Peng Zhang9
  • Yiping Zhang10
  • Peng Tang11
  • Yulong Zheng12
10 more authors
  • Yanping Liu13
  • Xiuyi Zhi14
  • Zhancheng Gao15
  • Qingxia Fan16
  • Huiming Cai17
  • Fugen Li17
  • Xiaoning Guo17
  • Bo Zhang17
  • Rongji Mu18
  • Zhangsheng Yu18
18 affiliations
  1. 1Department of Thoracic Surgery, Shanghai East Hospital Shanghai Tongji University School of Medicine Shanghai China.
  2. 2Department of Medical Oncology, Shanghai East Hospital Shanghai Tongji University School of Medicine Shanghai China.
  3. 3Department of Radiation Oncology, Shanghai Chest Hospital Shanghai Jiao Tong University School of Medicine Shanghai China.
  4. 4Radiotherapy Center Fudan University Shanghai Cancer Center Shanghai China.
  5. 5Department of Thoracic Surgery Sun Yat-Sen University Cancer Center Guangzhou China.
  6. 6Department of Medical Oncology Fujian Medical University Union Hospital Fuzhou China.
  7. 7Department of Oncology The Second Affiliated Hospital of Air Force Medical University Xi'an China.
  8. 8Department of Thoracic Medicine Hunan Cancer Hospital Changsha China.
  9. 9Department of Cardiothoracic Surgery Tianjin Medical University General Hospital Tianjin China.
  10. 10Department of Medical Oncology Zhejiang Cancer Hospital Hangzhou China.
  11. 11Department of Esophageal Oncology Tianjin Cancer Hospital Tianjin China.
  12. 12Department of Medical Oncology, The First Affiliated Hospital Zhejiang University School of Medicine Hangzhou China.
  13. 13Department of Oncology China Shenyang The Tenth People's Hospital Shenyang China.
  14. 14Department of Thoracic Surgery Xuanwu Hospital Capital Medical University Beijing China.
  15. 15Department of Respiratory Medicine Peking University People's Hospital Beijing China.
  16. 16Department of Medical Oncology The First Affiliated Hospital of Zhengzhou University Zhengzhou China.
  17. 17Haihe Biopharma Co., Ltd Shanghai China.
  18. 18Institute of Clinical Medicine Shanghai Jiao Tong University School of Medicine Shanghai China.
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Abstract

Advanced thymic carcinoma is a rare, aggressive malignancy with limited treatment options after chemotherapy failure. This randomized, double-blind, placebo-controlled trial (AL3810-202) aimed to evaluate lucitanib, a novel, orally potent tyrosine kinase inhibitor targeting VEGFR1‒3, FGFR1‒3, and PDGFRα/β in patients with advanced thymic carcinoma progressing after chemotherapy. Sixty-eight patients were randomized (2:1) to receive 10 mg lucitanib daily (n = 46) or placebo (n = 22). Although this study did not meet its primary endpoint of independent review committee (IRC)-assessed progression-free survival (PFS) (median 5.8 vs. 3.7 months; hazard ratio [HR]: 0.60; p = 0.1050), the prespecified log-rank test may have underestimated the treatment effect due to an observed non-proportional hazards pattern. Subsequent restricted mean survival time analysis demonstrated a statistically significant PFS benefit (p < 0.05), which was further supported by significantly prolonged investigator-assessed PFS (6.6 vs. 1.9 months; HR: 0.53; p = 0.0306). The most common grade 3 treatment-related adverse events (TRAEs) were hypertension (50%), proteinuria (15.2%), and thrombocytopenia (8.7%), with no grade 4/5 events. Considering the totality of the evidence and an acceptable safety profile, lucitanib may confer a meaningful clinical benefit for patients with advanced thymic carcinoma, warranting further investigation.

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Cite

BibTeXRIS
BibTeX
@article{fang2026efficacy,
  title = {{Efficacy and Safety of Lucitanib in Advanced Thymic Carcinoma: A Randomized Phase II Trial.}},
  author = {Wentao Fang and Caicun Zhou and Changlu Wang and Kailiang Wu and Jianhua Fu and Xiaoyan Lin and Helong Zhang and Jianhua Chen and Peng Zhang and Yiping Zhang and Peng Tang and Yulong Zheng and Yanping Liu and Xiuyi Zhi and Zhancheng Gao and Qingxia Fan and Huiming Cai and Fugen Li and Xiaoning Guo and Bo Zhang and Rongji Mu and Zhangsheng Yu},
  journal = {MedComm},
  year = {2026},
  month = oct,
  doi = {10.1002/mco2.71105},
  url = {https://europepmc.org/article/MED/42928801},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Efficacy and Safety of Lucitanib in Advanced Thymic Carcinoma: A Randomized Phase II Trial.
AU  - Wentao Fang
AU  - Caicun Zhou
AU  - Changlu Wang
AU  - Kailiang Wu
AU  - Jianhua Fu
AU  - Xiaoyan Lin
AU  - Helong Zhang
AU  - Jianhua Chen
AU  - Peng Zhang
AU  - Yiping Zhang
AU  - Peng Tang
AU  - Yulong Zheng
AU  - Yanping Liu
AU  - Xiuyi Zhi
AU  - Zhancheng Gao
AU  - Qingxia Fan
AU  - Huiming Cai
AU  - Fugen Li
AU  - Xiaoning Guo
AU  - Bo Zhang
AU  - Rongji Mu
AU  - Zhangsheng Yu
PY  - 2026
DA  - 2026/10/25
JO  - MedComm
DO  - 10.1002/mco2.71105
UR  - https://europepmc.org/article/MED/42928801
AB  - Advanced thymic carcinoma is a rare, aggressive malignancy with limited treatment options after chemotherapy failure. This randomized, double-blind, placebo-controlled trial (AL3810-202) aimed to evaluate lucitanib, a novel, orally potent tyrosine kinase inhibitor targeting VEGFR1‒3, FGFR1‒3, and PDGFRα/β in patients with advanced thymic carcinoma progressing after chemotherapy. Sixty-eight patients were randomized (2:1) to receive 10 mg lucitanib daily (n = 46) or placebo (n = 22). Although this study did not meet its primary endpoint of independent review committee (IRC)-assessed progression-free survival (PFS) (median 5.8 vs. 3.7 months; hazard ratio [HR]: 0.60; p = 0.1050), the prespecified log-rank test may have underestimated the treatment effect due to an observed non-proportional hazards pattern. Subsequent restricted mean survival time analysis demonstrated a statistically significant PFS benefit (p < 0.05), which was further supported by significantly prolonged investigator-assessed PFS (6.6 vs. 1.9 months; HR: 0.53; p = 0.0306). The most common grade 3 treatment-related adverse events (TRAEs) were hypertension (50%), proteinuria (15.2%), and thrombocytopenia (8.7%), with no grade 4/5 events. Considering the totality of the evidence and an acceptable safety profile, lucitanib may confer a meaningful clinical benefit for patients with advanced thymic carcinoma, warranting further investigation.
SN  - 2688-2663
ER  -