Phase II Study of Docetaxel and TS-1 Combination Therapy for Outpatients with Relapsed or Refractory Non-small Cell Lung cancer

Phase II Study of Docetaxel and TS-1 Combination Therapy for Outpatients with Relapsed or Refractory Non-small Cell Lung cancer - Phase II Study of Docetaxel and TS-1 Combination Therapy for Relapsed or Refractory Non-small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000501

Enrollment

Registered

2006-10-12

Start date

2006-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Non-small Cell Lung Cancer

Interventions

Docetaxel is intravenously at 40 mg/m2 on day1, and TS-1 is orally given at 80mg/m2/day from day1 to 14 every 3weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed stage IIIB, IV, or recurrent NSCLC 2) Measurable lesions (RECIST) 3) Relapsed or refractory to prior chemotherapy or chemoradiotherapy (< 3 regimes, exclusive of postoperative Tegafur-Uracil) 4) Complete recovery from hematological adverse effct of prior therapy 5) No intrathoracic irradiation within twelve weeks or recovery from toxicity due to irradiation within twelve weeks 6) P.S.(ECOG) 0-1 7) Age ranging from 20-74 years 8) Sufficient organ functions within two weeks. Defined as: 1. white blood cell count <=12,000/mm3 2. neutrophil count>=2000/mm3 3. platelet>=100,000/mm3 4. hemoglobin>=9.0 g/dl 5. AST and ALT within two times the upper limit of normal for the institution 6. serum bilirubin level<=1.5 mg/dl 7. serum creatinine level<=1.5 mg/dl 8. normal ECG 9. SaO2 >= 94% (room air) 9) Expected survival over 3 months 10) Possible to oral intake 11) Provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Active ineterstitial pneumonitis 2) History of using TS-1 or docetaxel 3) Active infectious disease 4) Active hepatitis or hepatocirrhosis 5) Active concomitant malignancy 6) Uncontrollable diabetes 7) Serious cardiac disease 8) Psycologic illness 9) Other severe complications 10) Pleural or pericardial effusion, or ascites requiring treatment 11) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 12) Regular use of warfarin 13) Regular use of fenitoin or frucitocin 14) High fever 15) Clinical symptom of brain metastases 16) Serious nephropathy and/or edema 17) Regular use of steroid 18) Medical history of serious allergy reactions to any drug 19) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
overall survival, progression-free survival, adverse events	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026