Lonsurf 20 mg/8.19 mg film-coated tablets
Sponsors
Regeneron Pharmaceuticals Inc., Agenus Inc., Bristol Myers Squibb International Corporation, Centre Hospitalier Universitaire De Dijon, AstraZeneca AB
Conditions
Advanced breast cancerAdvanced/Metastatic Gastric cancerColon carcinomaColorectal Cancer (CRC)Gastric cancerGastroesophageal Junction Adenocarcinoma Expressing Claudin18.2Metastatic Colorectal CancerMetastatic colorectal cancer
Phase 1
Phase 2
A Randomized, Open-label, Phase 2 study of Botensilimab (AGEN1181) as Monotherapy and in Combination with Balstilimab (AGEN2034) or Investigator’s Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer
Active, not recruitingCTIS2022-502065-23-00
Start: 2023-06-01Target: 102Updated: 2025-06-24
LOGICAN : Randomised phase II study evaluating trifluridine/tipiracil plus oxaliplatin ± nivolumab versus FOLFOX ± nivolumab in patients with HER2 negative locally advanced, recurrent or metastatic gastric, oesophageal or junctional adenocarcinoma
RecruitingCTIS2024-512999-35-00
Start: 2023-06-23Target: 118Updated: 2025-12-11
TRIFLUOX-DP: Safety of Trifluridine/tipiracil as replacement of fluoropyrimidines (5-fluorouracil and capecitabine) based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase deficiency: a phase II trial
RecruitingCTIS2023-508724-35-00
Start: 2024-12-10Target: 73Updated: 2025-06-20
A phase 1/2 study exploring the safety and activity of Trifluridine/Tipiracil in combination with Capecitabine and Bevacizumab in metastatic colorectal cancer patients. The TriComB trial
Not yet recruitingCTIS2024-513271-41-00
Target: 36Updated: 2024-09-16
Prospective, randomized, open, multicenter Phase II trial to investigate the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatment of metastatic colorectal cancer - FIRE-8 - AIO-KRK/YMO-0519
RecruitingCTIS2024-513723-16-00
Start: 2021-10-21Target: 153Updated: 2025-11-12
Sequential immunochemotherapy treatment with Pembrolizumab plus Dendritic Cell (DC) Vaccine followed by Trifluridine/Tipiracil plus Bevacizumab in refractory mismatch-repair-proficient (pMMR) or microsatellite-stable (MSS) metastatic colorectal cancer
RecruitingCTIS2024-514053-30-00
Start: 2025-01-07Target: 36Updated: 2024-11-07
A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy
(BOOG 2019-01 TIBET study)
Active, not recruitingCTIS2024-519204-27-00
Start: 2020-09-25Target: 50Updated: 2024-11-15
An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Trifluridine–tipiracil plus Bevacizumab Versus Trifluridine–tipiracil plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease
RecruitingCTIS2024-520356-24-00
Start: 2025-12-01Target: 35Updated: 2025-11-21
Efficacy and safety of trifluridin/tipiracil in combination with nanoliposomal irinotecan as a second line therapy in patients with cholangiocarcinoma
RecruitingCTIS2024-517330-18-00
Start: 2025-10-02Target: 38Updated: 2025-11-10
A phase II, open label, multicenter trial investigating Irinotecan plus cetuximab rechallenge compared with trifluridine/tipiracil plus bevacizumab as third line treatment in circulating tumor DNA molecularly selected metastatic colorectal cancer: the ROMANCE-GOIM trial
Not yet recruitingCTIS2025-521319-38-00
Target: 150Updated: 2026-01-19
Phase 3
PRODIGE 88-CIRCULATE PAC: Phase III multicentric, open-label, randomized study to investigate the efficacy of chemotherapy in patients with positive ctDNA after surgery and adjuvant chemotherapy for a high-risk stage II and stage III Colorectal Cancer
Not yet recruitingCTIS2023-505046-26-00
Target: 249Updated: 2025-10-20
A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixeddose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal Cancer
CompletedCTIS2023-503797-21-00
Start: 2022-08-10End: 2025-07-14Target: 233Updated: 2025-06-26
A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin 18.2 (CLARITY-Gastric 01)
RecruitingCTIS2023-508276-11-00
Start: 2025-01-17Target: 91Updated: 2025-09-15
A Phase 3 Multicenter, Randomized, Openlabel, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator’s Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation
Active, not recruitingCTIS2024-511187-81-00
Start: 2022-03-28Target: 99Updated: 2025-07-17
An open-label, randomised, phase III study comparing trifluridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy (SOLSTICE study).
RecruitingCTIS2024-516180-85-00
Start: 2019-04-15Target: 84Updated: 2025-09-29
ENGIC 06 (PRODIGE 114) – FFCD 2401 – FRUQUITAS
Randomized phase III trial to compare trifluridine/tipiracil + Fruquintinib versus trifluridine/tipiracil alone for metastatic oeso-gastric adenocarcinoma.
RecruitingCTIS2025-522395-92-00
Start: 2025-12-15Target: 284Updated: 2025-11-10
AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff
Not yet recruitingCTIS2024-512804-20-00
Target: 87Updated: 2025-12-10