Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer

Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer - Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001960

Enrollment

Registered

2009-06-01

Start date

2006-10-01

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

Non-small cell lung cancer

Interventions

CPT-11 is administered intravenously on day 1 and day 8 every 21 days. S-1 is administered given orally from day 1 to day 14 every 21 days.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Patients with histlogically or cytologically confirmed non-small cell lung cancer 2) Patients with mesearable lesions as defined by RECIST 3) Patients with the prior one chemotherapy except molecular-targeted drug 4) Performance Status(ECOG) 0-2 5) Patients with adequate organ functions WBC >= 4000/mm3 and <= 12,000/mm3 neutrophil count >= 2000/mm3 Platelet count >= 100,000/mm3 Hemoglobin >= 9.0g/dl AST, ALT <= 100IU/L Total bilirubin <= 1.5 mg/dl Serum creatinine <= 1.5 mg/dl PaO2 >= 70 torr (if the reason of hypoxemia is the primary disease, PaO2 >= 60 torr) 6) >= 70 years of age 7) Life expectancy more than three months 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with infections 2) Patients with massive pleural or pericardial effusion ,or ascites 3) Patients with pulmonary fibrosis interstitial pneumonia 4) Patients with diarrhea 5) Patients with intestinal paralysis or intestinal obstruction 6) Patients clinically important heart disease 7) Patients with significant complications 8) Patients with pregnancy or lactation 9) Patients with active concomitant malignancy 10) Patients with symptomatic brain metastasis 11) Patients in the administration of flucytosine (12) Patients in the administration of atazanavir sulfate

Design outcomes

Primary

Measure	Time frame
Anticancer efficacy	—

Secondary

Measure	Time frame
Duration of effect, Progression free survival, overall survival (Median survival time, 1-year survival rate), Adverse events.	—

Countries

Japan

Outcome results

None listed

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