Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

Summary

To evaluate the efficacy and safety of Envafolimab Plus Docetaxel in combination with or without Trilaciclib versus docetaxel IN patients with advanced non-small cell lung cancer previously treated with a PD-1 inhibitor combined with chemotherapy

Timeline

Start

2023-07-01

Primary completion

2025-12-30

Completion

2026-06-30

Publications

• Background Morimoto Y, Kishida T, Kotani SI, Takayama K, Mazda O. Interferon-beta signal may up-regulate PD-L1 expression through IRF9-dependent and independent pathways in lung cancer cells. Biochem Biophys Res Commun. 2018 Dec 9;507(1-4):330-336. doi: 10.1016/j.bbrc.2018.11.035. Epub 2018 Nov 14.
• Results Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.
• Results Boyero L, Sanchez-Gastaldo A, Alonso M, Noguera-Ucles JF, Molina-Pinelo S, Bernabe-Caro R. Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy. Cancers (Basel). 2020 Dec 11;12(12):3729. doi: 10.3390/cancers12123729.
• Results Herbst RS, Garon EB, Kim DW, Cho BC, Gervais R, Perez-Gracia JL, Han JY, Majem M, Forster MD, Monnet I, Novello S, Gubens MA, Boyer M, Su WC, Samkari A, Jensen EH, Kobie J, Piperdi B, Baas P. Five Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1-Positive Advanced NSCLC. J Thorac Oncol. 2021 Oct;16(10):1718-1732. doi: 10.1016/j.jtho.2021.05.001. Epub 2021 May 26.
• Results Law AMK, Valdes-Mora F, Gallego-Ortega D. Myeloid-Derived Suppressor Cells as a Therapeutic Target for Cancer. Cells. 2020 Feb 27;9(3):561. doi: 10.3390/cells9030561.
• Results Cabrita R, Mitra S, Sanna A, Ekedahl H, Lovgren K, Olsson H, Ingvar C, Isaksson K, Lauss M, Carneiro A, Jonsson G. The Role of PTEN Loss in Immune Escape, Melanoma Prognosis and Therapy Response. Cancers (Basel). 2020 Mar 21;12(3):742. doi: 10.3390/cancers12030742.
• Results Roselli M, Cereda V, di Bari MG, Formica V, Spila A, Jochems C, Farsaci B, Donahue R, Gulley JL, Schlom J, Guadagni F. Effects of conventional therapeutic interventions on the number and function of regulatory T cells. Oncoimmunology. 2013 Oct 1;2(10):e27025. doi: 10.4161/onci.27025.

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Indications