Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer

Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer - Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009399

Enrollment

Registered

2012-11-26

Start date

2012-11-26

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

Advanced Squamous Cell Lung Cancer

Interventions

nedaplatin,S-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stage IIIB or IV squamous cell lung carcinoma No indication of curable chemoradiation Chemonaive At least one measurable lesion Age>20 years Performance status of 0 to 1 Adequate main organ functions WBC>3000/mm3 NET>1500/mm3 Plt>100000/mm3 Hb>9.0g/dl T-bil<1.5mg/dl GOT<100 IU/L, GPT<100IU/L Creatinine<1.2mg/dL Creatinine clearance>60mL/min PaO2>60mmHg No limitation of outpatients Written informed consent

Exclusion criteria

Exclusion criteria: History of active other malignancy Severe heart disease Severe complication Intestinal pneumonia or lung fibrosis Severe diarrhea Massive pleural, cardiac, or abdominal effusion Regular use of fenitoin, warfarin or frucitocin Symptomatic brain metastasis History of severe drug allergic reaction Pregnant women or women willing child bearing Inadequate condition diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
To establish MTD and to determine the RD.	—

Secondary

Measure	Time frame
safty,PFS,OS and RR.	—

Countries

Japan

Outcome results

None listed

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