A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

NCT01904253 | Terminated Phase 2

• 2 other identifiers: TPU-TAS-102-2012012-004793-26
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 23

Brief 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.

Conditions

Small Cell Lung Cancer (SCLC)

Keywords

Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Through 30 days following last administration of study medication or until initiation of new anticancer treatment

Study Arms (2)

TAS-102

EXPERIMENTAL

Drug: TAS-102

Investigator Choice of Amrubicin or Topotecan

ACTIVE COMPARATOR

Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)

Drug: Amrubicin (Japan); Drug: Topotecan (Japan/Europe)

Interventions

TAS-102 DRUG

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.

TAS-102

Amrubicin (Japan) DRUG

Patients will receive treatment administered according to the country-specific approved prescribing information

Also known as: Calsed

Investigator Choice of Amrubicin or Topotecan

Topotecan (Japan/Europe) DRUG

Patients will receive treatment administered according to the country-specific approved prescribing information

Also known as: Hycamptin, Hycamtin

Investigator Choice of Amrubicin or Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (23)

Klinikum Mannheim GmbH Universitaetsklinikum

Mannheim, Baden-Wurttemberg, Germany

Location

Lungenklinik Heckeshorn- HELIOS Kliniken GmbH

Berlin, Germany

Location

LungenClinic Grosshansdorf

Großhansdorf, Germany

Location

Klinikum Koeln-Merheim

Koplin, Germany

Location

St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz

Mainz, Germany

Location

LMU-Campus Innenstadt

München, Germany

Location

Azienda Ospedaliero-Universitaria S. Luigi Gonzaga

Orbassano, Turin, Italy

Location

IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A

Aviano, Italy

Location

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, Italy

Location

Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

Catania, Italy

Location

Azienda Ospedaliera Instituti Ospitalieri di Cremona

Cremona, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

IEO Istituto Europeo di Oncologia

Milan, Italy

Location

Azienda Ospedaliera San Gerardo U.O Oncologia Medica

Monza, Italy

Location

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

Reggio Emilia, Italy

Location

A.O.V.V. Ospedale Eugenio Morelli-Sondalo

Sondalo, Italy

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Kyushi Cancer Center

Fukuoka, 811-1395, Japan

Location

Hyogo Cancer Center

Hyōgo, 673-8588, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, 135-8550, Japan

Location

Related Publications (1)

• 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.

  PMID: 27597276 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

trifluridine tipiracil drug combination; amrubicin; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Giorgio Scagliotti, MD

  University of Turin San Luigi Hospital

  PRINCIPAL INVESTIGATOR

• Kaoru Kubota, MD, PhD

  Nippon Medical School Hospital Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 22, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

JP (7); DE (6); IT (10)