Table 3.
Ongoing clinical trials involving epigenetic therapeutic agents for treatment of lung cancer patients, as of December 31, 2013.
| Clinical Trial | Phase | Protocol IDs | Intervention(s) |
|---|---|---|---|
| HDAC Inhibitors
| |||
| Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer | II | CDM204, NCT01836679 | Evaluate the efficacy and safety of chidamide (CS055/HBI8000; benzamide class HDI) combined with paclitaxel and carboplatin in patients with advanced NSCLC |
| Chemotherapy With or Without Epigenetic Priming in NSCLC Patients | II | J1309, NCT01846897 | To evaluate the efficacy of epigenetic priming by 5-azacytidine (U-18496; DNMT inhibitor) and entinostat (MS 275/SNDX-275; benzamide class HDI) prior to treatment with standard chemotherapy for NSCLC patients |
| Phase II Anti-PD1 Epigenetic Priming Study in NSCLC | II | J1353, NA_00084192, NCT01928576 | Determine the response rate to Nivolumab following epigenetic priming with 5-azacitidine (U-18496; DNMT inhibitor) with or without entinostat (MS 275/SNDX-275; benzamide class HDI) for NSCLC patients |
| Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) | I | FER-TH-031, NCI-2010-01913, NCT01059552 | Determine the maximum tolerated dose of the combination of vorinostat (L-001079038; suberoylanilide hydroxamic acid HDI), cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB NSCLC |
| Study of Cisplatin and Pemetrexed in Combination With Panobinostat in Solid Tumors | I | UCDCC#220, NCT01336842 | Determine if panobinostat (LBH589; cinnamic hydroxamic acid analogue HDI) can be safely combined with cisplatin and pemetrexed without increasing side effects and that the combination will be more efficacious than platinum-based doublet chemotherapy alone in solid tumor patients (including NSCLC) |
| A Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Non-small Cell Lung Cancer | I | J11102, NA_00052054, NCT01537744 | Determine if 5-azacitidine (U-18496; DNMT inhibitor) combined with intravenous romidepsin (FK228/FR901228/NSC 630176; depsipeptide HDI) is effective in the treatment of advanced solid tumors (including NSCLC) |
|
| |||
| DNMT Inhibitors
| |||
| A Multi-Histology Phase II Study of 5-Fluoro-2-Deoxycytidine With Tetrahydrouridine (FdCyd + THU) | II | 090214, 09-C-0214, NCT00978250 | Evaluate the efficacy of fluoro-2-deoxycytidine (FdCyd; DNMT inhibitor) combined with tetrahydrouridine for treatment of solid tumor patients (including NSCLC) |
Abbreviations: HDAC = histone deacetylase; DNMT = DNA methyltransferase; NSCLC = non-small cell lung cancer; HDI = histone deacetylase inhibitor