Phase 3
Completed N=507
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Source: ClinicalTrials.gov NCT02500043 ↗Enrolled (actual)
507
Serious AEs
42.4%
Results posted
Sep 2021
Primary outcomePrimary: Overall Survival (OS) — 5.7; 3.6 months — p=0.0003
◆ Published Evidence
Highly cited
521citations · ~65 / year
Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial.
Summary
The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.
Linked Publications (5)
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Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial.
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Efficacy and Safety of Trifluridine/Tipiracil Treatment in Patients With Metastatic Gastric Cancer Who Had Undergone Gastrectomy: Subgroup Analyses of a Randomized Clinical Trial.
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Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS.
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Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS).
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Cost-effectiveness analysis of trifluridine/tipiracil in the treatment of heavily pretreated metastatic gastric cancer from the perspective of Chinese healthcare system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
5.7; 3.6 | 0.0003 sig |
| SECONDARY Progression-Free Survival (PFS) |
2.0; 1.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) |
319; 151; 143; 70 | — |
Eligibility Criteria
Inclusion Criteria
- Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
- Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
- Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Is able to take medications orally (ie, no feeding tube).
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Has adequate organ function as defined by protocol defined labs.
- Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion Criteria
- Has certain serious illnesses or medical conditions
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration.
- Has previously received TAS-102.
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
- Is a pregnant or lactating female.
Data sourced from ClinicalTrials.gov (NCT02500043) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.