Clinical trial · Interventional
A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy
An Open-Label, Randomized, Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin in Patients Requiring Second-Line Chemotherapy for Small Cell Lung Cancer That is Refractory or Sensitive to First-Line Platinum-Based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms
Summary
Brief summary (as posted)
The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer (SCLC) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAS-102
- interventionNames
- Drug: TAS-102
- type
- ACTIVE_COMPARATOR
- label
- Investigator Choice of Amrubicin or Topotecan
- description
- Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)
- interventionNames
- Drug: Amrubicin (Japan)
- Drug: Topotecan (Japan/Europe)
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Every 6 weeks from the start of study treatment (Day 1, Cycle 1). Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has provided written informed consent 2. Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan 3. Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease) 4. Has progressed or had recurrence within 30 days prior to randomization 5. Has at least one measurable lesion, as defined by RECIST criteria version 1.1 6. ECOG performance status of 0, 1, or 2 7. Is able to take medications orally 8. Has adequate organ function (bone marrow, kidney and liver) 9. 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: 1. Has cerebral metastases (unless metastases have been treated and controlled, metastases have been stable for at least 2-months post-intervention, and patient is not receiving corticosteroid treatment) 2. Certain serious illnesses or medical condition(s) 3. 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 4. Has received TAS-102 5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 6. Is a pregnant or lactating female
References
Publications (1)
- DERIVEDScagliotti G, Nishio M, Satouchi M, Valmadre G, Niho S, Galetta D, Cortinovis D, Benedetti F, Yoshihara E, Makris L, Inoue A, Kubota K. A phase 2 randomized study of TAS-102 versus topotecan or amrubicin in patients requiring second-line chemotherapy for small cell lung cancer refractory or sensitive to frontline platinum-based chemotherapy. Lung Cancer. 2016 Oct;100:20-23. doi: 10.1016/j.lungcan.2016.06.023. Epub 2016 Jun 27. PMID 27597276