Table 4.
Ongoing and recently reported trials of FTD/TPI in combination with other agents in mCRC and other advanced solid tumors (up to date July 2022).
| Study name | Study ID | Setting | Agent(s) | Description and location(s) | Study status |
|---|---|---|---|---|---|
| Advanced mCRC | |||||
| SOLSTICE56 |
NCT03869892 EudraCT: 2017-004059-22 |
1L mCRC | FTD/TPI + BEV versus capecitabine + BEV | Randomized phase III (non-US international) | Active, not recruiting; preliminary results56 |
| TOBACO | NCT05077839 | 1L mCRC | FTD/TPI + oxaliplatin and BEV versus XELOX + BEV | Parallel, randomized, standard-control phase II study (China) | Recruiting |
| TriComB |
NCT04564898 EudraCT: 2020-000923-37 |
1L mCRC | FTD/TPI + Capecitabine and BEV | Single-arm, phase I/II (Italy) | Recruiting |
| FIRE-8 |
NCT05007132 EudraCT: 2019-004223-20 |
1L mCRC | FTD/TPI + panitumumab versus FTD/TPI + BEV | Randomized, open label, multicenter phase II (Germany) | Recruiting |
| TASCO1 | NCT02743221 | 1L mCRC | FTD/TPI + BEV versus capecitabine + BEV | Open-label, randomized phase II | Completed |
| SUNLIGHT |
NCT04737187 EudraCT: 2020-001976-14 |
1L, 2L, or 3L mCRC (refractory mCRC) | FTD/TPI + BEV versus FTD/TPI | Randomized phase III (US/global) | Active, not recruiting |
| (N/A) | UMIN000041621 | mCRC (all lines) | FTD/TPI + BEV | Pooled analysis of 5 trials (Japan) | Preinitiation |
| 3T Study | NCT05356897 | 2L+ mCRC | FTD/TPI + tucatinib + trastuzumab | Single-arm phase II study (US) | Not yet recruiting |
| (N/A) | NCT04294264 | 2L+ mCRC | FTD/TPI + oxaliplatin | Single-arm phase II study (US) | Recruiting |
| (N/A) | NCT02848443 | 2L+ mCRC | FTD/TPI + oxaliplatin (+/− BEV or nivolumab) | Phase I (UK/Europe) | Completed |
| TABAsCO | NCT04109924 | 2L+ mCRC | FTD/TPI + BEV + IRI | Single-arm phase II study (US) | Recruiting |
| WJOG14520G | UMIN000044136 | 2L+ mCRC | FTD/TPI + BEV | Retrospective study (Japan) | No longer recruiting |
| HS-CA102N-101 | NCT03616574 | 2L+ locally advanced/metastatic CRC | FTD/TPI + CA102N | Phase I/II | Enrolling by invitation |
| (N/A) | NCT04511039 | 2L+ locally advanced/mCRC or GEJC | FTD/TPI + Talazoparib | Phase I (US) | Recruiting |
| TASKIN | NCT05201352 | 2L+ mCRC | FTD/TPI + XB2001 versus FTD/TPI + placebo | Randomized (1:1 ratio), double-blind, noncomparative, multi-centre phase II study (France) | Not yet recruiting |
| (N/A) | NCT03317119 | 2L+ mCRC (unresectable) | FTD/TPI + trametinib | Phase I study (US) | Active, not recruiting |
| (N/A) | NCT05130060 | 3L+ mCRC | PolyPEPI1018 vaccine + FTD/TPI | Phase I study (US) | Recruiting |
| COLSTAR |
NCT05223673 EudraCT: 2021-003151-41 |
3L+ KRAS/NRAS and BRAF wt mCRC | Futuximab/modotuximab + FTD/TPI versus FTD/TPI | Randomized, open-label, multicenter, 2-arm phase III safety lead-in study | Recruiting |
| RM-110 | NCT04073615 | 3L+ mCRC | Rivoceranib + FTD/TPI versus monotherapies) | Phase I/II multicenter, open-label, randomized study (US) | Active, not recruiting |
| VELO |
NCT05468892 EudraCT: 2018-001600-12 |
3L+ mCRC (major response to prior 1L; progression on 2L) | FTD/TPI + panitumumab versus FTD/TPI | Open label, phase II randomized study | Completed |
| (N/A) | NCT04868773 | 3L+ mCRC | FTD/TPI + cabozantinib | Phase I study (US) | Recruiting |
| TACTIC | NCT05266820 | 3L+ mCRC | FTD/TPI + thalidomide versus FTD/TPI | Phase II study (China) | Recruiting |
| CT001 | NCT05155124 | 3L mCRC | FTD/TPI + cetuximab | Phase I study (China) | Recruiting |
| Other solid tumors | |||||
| ONC001 | NCT04393298 | 1L+ advanced solid tumors (including mCRC, mGC/mGEJC, others) | UCB6114 ± FTD/TPI | Phase I/II nonrandomized, open-label study (US/UK) (US/UK) | Recruiting |
| (N/A) | NCT04808791 | 1L locally advanced/metastatic GC/GEJ adenocarcinoma | IRI + FTD/TPI + oxaliplatin | Single-arm, phase II study (Canada) | Not yet recruiting |
| (N/A) | NCT04097028 | 1L resectable esophageal/GEJ adenocarcinoma | FTD/TPI + Oxaliplatin | Phase II trial (US) | Recruiting |
| MC1941 | NCT04072445 | 2L+ advanced refractory biliary tract cancer | FTD/TPI + IRI | Single-arm phase II study (US) | Active, not recruiting |
| (N/A) | NCT03368963 | 2L+ advanced GI cancers (dose expansion phase only: pancreatic/CRC) | TAS102 + nanoliposomal IRI | Phases I/II trial (US) | Recruiting |
| ACCRU-GI-1810 | NCT04660760 | 2L+ advanced GC/GEJC | FTD/TPI + ramucirumab versus paclitaxel + ramucirumab | Phase II randomized trial (US) | Recruiting |
| LonGas57 | EudraCT: 2018-004845-18 | Platinum-refractory GEJ adenocarcinoma | FTD/TPI ± BEV | Randomized phase III study (Denmark) | Completed; preliminary results57 |
| RE-ExPEL | EudraCT: 2020-001075-32 | Advanced/metastatic GC/GEJC | Ramucirumab beyond progression plus TAS-102 | Pilot study (Germany) | Ongoing |
| ACOTAS_G098 | EudraCT: 2020-004636-25 | mCRC/mGC/mGEJC | FTD/TPI ± oxaliplatin | Phase II cardiovascular safety study (France) | Ongoing |
| ACE1100-01 | EudraCT: 2021-003799-15 | 3L advanced GC | FTD/TPI + ASC-201 versus FTD/TPI | Randomized, double-blind phase II study (Spain) | Ongoing |
| TRITICC | NCT04059562 | 2L cholangiocarcinoma | FTD/TPI + IRI | Prospective, single arm, open label, exploratory, multi-centre pilot study (Germany) | Recruiting |
| (N/A) | EudraCT: 2018-002936-26 | 2L+ cholangiocarcinoma | FTD/TPI + IRI | Efficacy/safety study (Germany) | Restarted |
Abbreviations: 1L, first line; 2L, second line; 3L, third-line; BEV, bevacizumab; CRC, colorectal cancer; FTD/TPI, trifluridine/tipiracil; GC, gastric cancer; GEJC, gastroesophageal junction carcinoma; GI, gastrointestinal; ID, identifier; IRI, irinotecan; mCRC, metastatic colorectal cancer; N/A, not applicable; wt, wild type.