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NCT01904253
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
Phase 2 trial testing TAS-102 in Small Cell Lung Cancer (SCLC) in 18 participants. Terminated before completion.
1 June 2014
Quick facts
| Lead sponsor | Taiho Oncology, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 July 2013 |
| Primary completion | 1 June 2014 |
| Estimated completion | 1 June 2014 |
| Sites | 23 locations across Germany, Italy, Japan |
Drugs / interventions tested
- TAS-102
- Amrubicin (Japan) — full drug profile →
- Topotecan (Japan/Europe) — full drug profile →
Conditions studied
- Small Cell Lung Cancer (SCLC) — all drugs for Small Cell Lung Cancer (SCLC) →
Sponsor
Taiho Oncology, Inc. — full company profile →
Who can join
18 and older, any sex, with Small Cell Lung Cancer (SCLC). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Progression-free survival
Time frame: 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.
Tumor assessments will be performed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 every 6 weeks during study treatment, and every 8 weeks after treatment is completed. Tumor assessments will be performed from Day 1, Cycle 1 until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01904253
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TAS-102
Trials testing the same drug.
- NCT07196345 — TAS-102 Plus Radiotherapy in Elderly ESCC · Phase 1, PHASE2 · not yet recruiting
- NCT07116577 — Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC · Phase 2 · not yet recruiting
- NCT06346392 — AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic · Phase 3 · recruiting
- NCT05481463 — Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer · Phase 2 · completed
- NCT05600309 — A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated · Phase 3 · completed
Other recruiting trials for Small Cell Lung Cancer (SCLC)
Currently open trials in the same condition.
- NCT07480213 — Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC) · Phase 1, PHASE2 · recruiting
- NCT07434518 — A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC · recruiting
- NCT07510724 — Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab · recruiting
- NCT07226999 — Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adul · Phase 2, PHASE3 · recruiting
- NCT06745323 — A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC · Phase 2 · active not recruiting
Other Taiho Oncology, Inc. trials
Trials by the same sponsor.
- NCT07128199 — A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Sta · Phase 3 · recruiting
- NCT05973773 — REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) · Phase 3 · active not recruiting
- NCT05967689 — A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR · Phase 2 · recruiting
- NCT05765734 — A Study of TAS3351 in NSCLC Patients With EGFRmt · Phase 1 · terminated
- NCT05403450 — A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Partici · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01904253 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Taiho Oncology, Inc.
- Last refreshed: 30 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01904253.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing