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An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)



- Determine the antitumor activity of S-1 as second-line therapy, in terms of overall
response rate, in patients with unresectable or recurrent stage IIIB or IV non-small
cell lung cancer.


- Determine the duration of response, time to tumor progression, and overall survival of
patients treated with this drug.

- Determine the safety of this drug in these patients.

- Correlate S-1 plasma levels (components and metabolites) with safety and efficacy
parameters in patients treated with this drug.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 weeks until progressive
disease and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 30-95 patients will be accrued for this study.

Inclusion Criteria


- Histologically and/or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage IIIB disease with pleural or pericardial effusion

- Stage IV disease

- Unresectable or recurrent disease

- No mixed forms with small cell lung cancer

- Must have received 1 prior first-line combination chemotherapy (platinum- or
non-platinum-based) regimen

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No symptomatic, uncontrolled (by corticosteroids) brain metastasis

- No leptomeningeal metastasis



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL


- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver

- Bilirubin ≤ 1.5 times ULN


- Creatinine clearance ≥ 60 mL/min


- No myocardial infarction within the past 6 months

- No severe or unstable angina

- No New York Heart Association class III or IV congestive heart failure


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study

- No other active malignancy

- No psychiatric disorder or condition, severe acute or chronic medical condition, or
laboratory abnormality that would preclude study compliance

- No known HIV- or AIDS-related illness

- Able to take oral medication

- No known neuropathy ≥ grade 2

- No chronic nausea, vomiting, and/or diarrhea


Biologic therapy

- More than 3 weeks since prior immunotherapy or biologic therapy

- No concurrent immunotherapy

- No concurrent biologic response modifiers


- See Disease Characteristics

- No prior first-line treatment with S-1 for NSCLC

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- No other concurrent chemotherapy

- No other fluoropyrimidine-group antineoplastic agent within 7 days after the last
dose of S-1

Endocrine therapy

- See Disease Characteristics

- At least 3 weeks since prior hormonal therapy

- No concurrent endocrine therapy


- More than 2 weeks since prior radiotherapy

- Prior radiotherapy to a target lesion allowed provided the following criteria are

- No radiotherapy within the past 3 months

- Evidence of progressive disease after radiotherapy

- Target lesion is not the only site of measurable disease

- No concurrent radiotherapy


- Not specified


- More than 3 weeks since prior therapy for NSCLC

- At least 30 days since prior investigational agents

- No prior second-line therapy for NSCLC

- No other concurrent participation in another clinical trial

- No other concurrent investigational agent

- No concurrent administration of any of the following:

- Sorivudine

- Uracil

- Cimetidine

- Leucovorin calcium

- Dipyridamole

- Allopurinol

- Phenytoin

- Flucytosine

- No other concurrent drugs that may interact with S-1

- No other concurrent anticancer therapy

- No flucytosine within 7 days after the last dose of S-1

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate by CT scan and physical exam at the end of every even course or every 6 weeks until progressive disease (PD) or initiation of new anticancer therapy

Safety Issue:


Principal Investigator

Dawn Buchanan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taiho Pharma U.S.A., Incorporated


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



New York Medical College Valhalla, New York  10595
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Fountain Valley, California  92708
Miami, Florida  33176
Florida Cancer Institute - New Port Richey New Port Richey, Florida  34655
Associates in Oncology and Hematology Chattanooga, Tennessee  37404
Charleston Cancer Center Charleston, South Carolina  29406
Hematology Oncology Life Center Alexandria, Louisiana  71301
Compassionate Cancer Care Medical Group Incorporated - Fountain Valley Fountain Valley, California  92708
Western Hematology and Oncology Associates, PC Lakewood, Colorado  80215
Northwestern Connecticut Oncology Hematology Associates - Sharon Sharon, Connecticut  06069
Eastern Oncology Hematology Greenville, North Carolina  27834
New Bern Cancer Care New Bern, North Carolina  28560
Signal Point Hematology Oncology Incorporated Middletown, Ohio  45042
Vita Hematology Oncology at St. Luke's Hospital Bethlehem, Pennsylvania  18015