Small Cell Lung Cancer (SCLC)Phase 2NCT01904253
A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy
A Phase 2 study testing TAS-102, Amrubicin (Japan) and Topotecan (Japan/Europe) in people with Small Cell Lung Cancer (SCLC), run by Taiho Oncology, Inc. at 23 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- TAS-102, Amrubicin (Japan) and Topotecan (Japan/Europe)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Jul 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided written informed consent
- Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
- Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
- Has progressed or had recurrence within 30 days prior to randomization
- Has at least one measurable lesion, as defined by RECIST criteria version 1.1
- ECOG performance status of 0, 1, or 2
Show all 9Show fewer
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- 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.
Who cannot join
- 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)
- Certain serious illnesses or medical condition(s)
- 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 received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
Italy10 sites
IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A
Aviano
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
Catania
Azienda Ospedaliera Instituti Ospitalieri di Cremona
Cremona
Azienda Ospedaliera Universitaria Careggi
Florence
IEO Istituto Europeo di Oncologia
Milan
Azienda Ospedaliera San Gerardo U.O Oncologia Medica
Monza
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga
Orbassano, Turin
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia
A.O.V.V. Ospedale Eugenio Morelli-Sondalo
Sondalo
Japan7 sites
National Cancer Center Hospital East
Chiba, 277-8577
National Kyushi Cancer Center
Fukuoka, 811-1395
Hyogo Cancer Center
Hyōgo, 673-8588
Saitama Cancer Center
Saitama, 362-0806
Shizuoka Cancer Center
Shizuoka, 411-8777
Nippon Medical School Hospital
Tokyo, 113-8603
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, 135-8550
Germany6 sites
Lungenklinik Heckeshorn- HELIOS Kliniken GmbH
Berlin
LungenClinic Grosshansdorf
Großhansdorf
Klinikum Koeln-Merheim
Koplin
St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz
Mainz
Klinikum Mannheim GmbH Universitaetsklinikum
Mannheim, Baden-Wurttemberg
LMU-Campus Innenstadt
München
About this study
Official title: 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
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.
Read the detailed description
This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression < 90 days after the last dose.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- TAS-102, Amrubicin (Japan), Topotecan (Japan/Europe)
- Keywords
- Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Amrubicin (Japan)Drug
Also called Calsed
Patients will receive treatment administered according to the country-specific approved prescribing information
Topotecan (Japan/Europe)Drug
Also called Hycamptin, Hycamtin
Patients will receive treatment administered according to the country-specific approved prescribing information
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 | Experimental | Not described Receives: Drug: TAS-102 |
| Investigator Choice of Amrubicin or Topotecan | Active comparator | Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan) Receives: Drug: Amrubicin (Japan); Drug: Topotecan (Japan/Europe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
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 target number of events (deaths) is met.
Measured: 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.
Secondary outcomes (2)
Overall survival
Measured: Survival status will be collected at 8-week intervals until death, for up to 12 months after the first dose of study medication for the last patient randomized or until the target number of events (deaths) is met, whichever is later.
Safety monitoring including adverse events, vital signs, and laboratory assessments
Standard safety monitoring will be performed and adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Measured: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Giorgio Scagliotti, MD, Principal investigator, University of Turin San Luigi HospitalKaoru Kubota, MD, PhD, Principal investigator, Nippon Medical School Hospital Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904253
- Sponsor's protocol ID
- TPU-TAS-102-201
- Other IDs
- 2012-004793-26
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2013
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Scagliotti 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.
PubMed 27597276
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01904253
- Acronym / sponsor ID
- TPU-TAS-102-201
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression < 90 days after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-102 | Experimental | Drug: TAS-102 |
| Investigator Choice of Amrubicin or Topotecan | Active comparator | Drug: Amrubicin (Japan), Drug: Topotecan (Japan/Europe)Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has provided written informed consent
- Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
- Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
- Has progressed or had recurrence within 30 days prior to randomization
- Has at least one measurable lesion, as defined by RECIST criteria version 1.1
Key exclusion criteria (6 listed)
- 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)
- Certain serious illnesses or medical condition(s)
- 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 received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-10235 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. | Drug | TAS-102 |
| Amrubicin (Japan)Also: CalsedPatients will receive treatment administered according to the country-specific approved prescribing information | Drug | Investigator Choice of Amrubicin or Topotecan |
| Topotecan (Japan/Europe)Also: Hycamptin, HycamtinPatients will receive treatment administered according to the country-specific approved prescribing information | Drug | Investigator Choice of Amrubicin or Topotecan |
Primary outcome
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 target number of events (deaths) is met.
2 secondary outcomes
Overall survival
Time frame: Survival status will be collected at 8-week intervals until death, for up to 12 months after the first dose of study medication for the last patient randomized or until the target number of events (deaths) is met, whichever is later.
Safety monitoring including adverse events, vital signs, and laboratory assessments
Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Results and safety
The study was stopped early (reason given: The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 27597276Scagliotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Scagliotti, MD principal investigator
University of Turin San Luigi Hospital
Kaoru Kubota, MD, PhD principal investigator
Nippon Medical School Hospital Cancer Center
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-102, Amrubicin (Japan) and Topotecan (Japan/Europe) in people with Small Cell Lung Cancer (SCLC), run by Taiho Oncology, Inc. at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Italy, Japan, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.