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A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced lung squamous cell carcinoma

A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced lung squamous cell carcinoma - Phase II study of S-1continuation maintenance therapy following CBDCA/S-1 in lung squamous cell carcinoma NSCLC :S-COT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006983
Enrollment
50
Registered
2012-01-01
Start date
2012-01-01
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

Lung cancer

Interventions

Patients receive 4 courses of CBDCA/S-1. Chemotherapy with S-1 is continued for patients who do not have PD

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or pathologically proven lung squamous cell carcinoma 2) Locally advanced or metastatic, recurrent non-small cell lung cancer 3) Age more than 20 years 4) Performance status (ECOG) of 0-1 5) Life expectancy of more than 3 months 6) Patients with ability of oral intake 7) Patients who has at least one or more measurable lesion by RECIST 8) Patients who have adequate organ function 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who received previous treatment with the 5-FU 2) Patients who is contraindicated to administration of CBDCA and S-1 3) Patients with a history of the drug hypersensitivity 4) Patients with symptomatic metastases to brain 5) Uncontrolled massive pleural effusion, ascitic fluid and pericardial fluid retention case 6) Patients with watery diarrhea 7) Patients with serious complications 8) Patients with active concomitant malignancy 9) Patients with HBs antigen-positive or with HCV antibody-positive 10) Patients who uses flucytosine 11) Women with the pregnant possibility, a pregnancy or lactation and men with willing to get pregnant 12) Patients who were complicated with mental disease or neurologic manifestation, and it is judged that the participation in study is difficult 13) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
Overall survival, 1-year survival Rate, Response Rate, Safety

Countries

Japan

Contacts

Public ContactYasuhiro Ito

Hamamatsu University School of Medicine The Second Division, Department of Internal Medicine

Outcome results

None listed

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