Last Updated: May 29, 2026

CLINICAL TRIALS PROFILE FOR LONSURF


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505(b)(2) Clinical Trials for lonsurf

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Novotech (Australia) Pty Limited PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Kahr Bio Australia Pty Ltd PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for lonsurf

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01896856 ↗ Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer Completed Astex Pharmaceuticals, Inc. Phase 1/Phase 2 2013-10-23 This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗ Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer Completed Van Andel Research Institute Phase 1/Phase 2 2013-10-23 This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗ Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer Completed Sidney Kimmel Comprehensive Cancer Center Phase 1/Phase 2 2013-10-23 This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗ Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer Completed Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Phase 1/Phase 2 2013-10-23 This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for lonsurf

Condition Name

Condition Name for lonsurf
Intervention Trials
Metastatic Colorectal Cancer 9
Colorectal Cancer 6
Stage IVC Colorectal Cancer AJCC v8 6
Stage IV Colorectal Cancer AJCC v8 6
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Condition MeSH

Condition MeSH for lonsurf
Intervention Trials
Colorectal Neoplasms 33
Adenocarcinoma 20
Carcinoma 10
Colonic Neoplasms 7
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Clinical Trial Locations for lonsurf

Trials by Country

Trials by Country for lonsurf
Location Trials
United States 133
Australia 18
Japan 17
Taiwan 8
France 7
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Trials by US State

Trials by US State for lonsurf
Location Trials
Florida 13
California 13
Texas 11
Minnesota 9
Arizona 9
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Clinical Trial Progress for lonsurf

Clinical Trial Phase

Clinical Trial Phase for lonsurf
Clinical Trial Phase Trials
PHASE3 1
PHASE2 2
PHASE1 1
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Clinical Trial Status

Clinical Trial Status for lonsurf
Clinical Trial Phase Trials
Recruiting 30
Active, not recruiting 10
Not yet recruiting 10
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Clinical Trial Sponsors for lonsurf

Sponsor Name

Sponsor Name for lonsurf
Sponsor Trials
National Cancer Institute (NCI) 14
Taiho Oncology, Inc. 8
Academic and Community Cancer Research United 5
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Sponsor Type

Sponsor Type for lonsurf
Sponsor Trials
Other 70
Industry 36
NIH 14
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