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Lonsurf 15 mg/6.14 mg film-coated tablets

DRUG20 trials

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)FGFR2b-positiveGastric cancerGastroesophageal Junction Adenocarcinoma Expressing Claudin18.2Metastatic 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
Agenus Inc.Refractory Metastatic Colorectal Cancer
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
Unicanceroesophagus or gastroesophageal junction adenocarcinoma, Patients with HER 2 negative locally advanced, recurrent or metastatic gastric
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
Unicancergastroesophageal junction and gastric) and with known dihydropyrimidine dehydrogenase (DPD) deficiency defined as plasma uracil concentration ≥16 ng/ml, Patients with pMMR/MSS metastatic adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower esophagus, who undergo first-line treatment
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
Gruppo Oncologico Del Nord Ovest, Gruppo Oncologico Del Nord Ovestcolorectal metastatic cancer, metastatic colorectal cancer
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
Charite Universitaetsmedizin Berlin KöRmetastatic colorectal cancer
Start: 2021-10-21Target: 153Updated: 2025-11-12
Bemarituzumab in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, who failed at least one prior line of palliative chemotherapy - The IKF-AIO Phase IIa BEMARA trial
Active, not recruitingCTIS2024-512484-31-00
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbHadvanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, FGFR2b-positive
Start: 2025-02-28Target: 146Updated: 2026-01-06
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
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.Metastatic colorectal cancer
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
BOOG Study Center B.V.Advanced breast cancer
Start: 2020-09-25Target: 50Updated: 2024-11-15
Investigate the efficacy and safety of a bio-marker driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.
RecruitingCTIS2024-518534-81-00
Gruppo Oncologico Dell'Italia Meridionalemetastatic colorectal cancer
Start: 2021-07-01Target: 200Updated: 2025-08-28
– IKF/AIO-QUINTIS – A Randomized Phase II Trial Evaluating Fruquintinib in Combination with Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer without Active Liver Metastases
RecruitingCTIS2024-519929-38-00
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbHMetastatic Colorectal Cancer without liver metastases
Start: 2025-10-27Target: 140Updated: 2025-10-27
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
Delcath Systems Inc.Refractory Metastatic Colorectal Cancer with Liver Dominant Disease
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
Heinrich-Heine-Universitaet Duesseldorfadvanced, non resectable or metastatic cholangio- or gallbladder carcinoma after failure to respond to a previous gemcitabine treatment
Start: 2025-10-02Target: 38Updated: 2025-11-10

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
Centre Hospitalier Universitaire De DijonColon carcinoma
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
Bristol Myers Squibb International CorporationMetastatic Colorectal Cancer
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
AstraZeneca ABAdvanced/Metastatic Gastric cancer, Gastric cancer, Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
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
Amgen Inc.Colorectal Cancer (CRC)
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
Institut De Recherches Internationales Servier IRISMetastatic colorectal cancer
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
Fondation Franc.Cancerologie Digestivemetastatic oeso-gastric adenocarcinoma
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
AbbVie Deutschland GmbH & Co. KGMetastatic Colorectal Cancer
Target: 87Updated: 2025-12-10