Promising cancer drug falls short in rare tumor trial
NCT ID NCT04042714
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug TAS-102 (also known as Lonsurf) in 14 people with a rare and aggressive type of neuroendocrine cancer that started outside the lungs. The goal was to see if the drug could shrink tumors or improve survival. The trial was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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14 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologic confirmation of high grade NEC using WHO criteria as determined by Ki67\>20%, poorly differentiated (G3) characteristics, or \>20 mitotic figures/10 high-power fields. * Unknown primary may be included. Suspected extrapulmonary patients with known lung primary will be excluded. * Prior treatment with a platinum containing regimen * RECIST 1.1 measurable disease * Evidence of stage IV, metastatic disease * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. * Serum albumin ≥2.5 gm/dL. * Expected survival ≥3 months. * Adequate hematologic function as defined by: a) Absolute neutrophil count (ANC) \>1500/mm3; b) Platelets ≥75,000/mm3; c) Hemoglobin \>8 g/dL (in the absence of red blood transfusion). * Adequate liver function, as defined by: a) Serum total bilirubin ≤2.5 x ULN mg/dL. b) ALT (SGPT) and AST (SGOT) ≤5 x upper limit of normal (ULN). * Adequate renal function, as defined by serum creatinine ≤2.0 x ULN, or creatinine clearance ≥30 mL/min * Females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Evidence of low-grade or well-differentiated features as determined by the investigator. * Functional neuroendocrine tumors are excluded. * Known pulmonary primary or small cell lung cancer will be excluded. * Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months. * Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38°C). * Other severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: a) Severe impaired lung functions as defined by spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air, b) Uncontrolled diabetes,c) Liver disease such as cirrhosis or severe hepatic impairment, d) Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the integrity of the study. * Taking other investigational or anti-cancer treatments while participating in this study. Concurrent radiotherapy is allowed provided to non-target lesions. If target lesions have received radiation therapy, progression must have been demonstrated prior to enrollment. * Prior or concurrent malignancy, except for the following: a) Adequately treated basal cell or squamous cell skin cancer; b) Cervical carcinoma in situ; c) Adequately treated Stage I or II cancer from which the subject is currently in complete remission; d) Or any other cancer from which the subject has been disease-free for 3 years.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Scott and White University Medical Center,
Dallas, Texas, 75246, United States