Phase I study of TS-1 and Nedaplatin for previously untreated patients with advanced squamous cell carcionoma of lung

Phase I study of TS-1 and Nedaplatin for previously untreated patients with advanced squamous cell carcionoma of lung - Phase I study of TS-1 and CDGP for sq. cell carcioma of lung

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009760

Enrollment

Registered

2013-01-11

Start date

2013-01-11

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

Squamous cell carcinoma of lung

Interventions

TS-1 is administered at fixed doses based on the body surface area (BSA) of the patient (BSA&lt

1.25 m2 80mg/day

BSA 1.25-1.5 m2 100mg/day

BSA&gt

1.5 m2 120mg/day) on day 1-14 q3w. Nedaplatin is administered at a dose of allocated level q3w. Level 1 60 mg/m2 Level 2 70 mg/m2 Level 3 80 mg/m2 Level 4 90 mg/m2 Level 5 100 mg/m2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Previously untreated patients with histologically or cytologically proven squamous carcinoma of lung (include post surgical recurrence) 2.With one or more measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 3.No indication of radical radiotherapy, Stage IIIB or IV 4.Age over 18 5.Performance Status (ECOG): 0 to 1 6.Adequate major organ functions WBC>=3,000/uL Neutro>=2,000/uL Hgb>=9.5 g/dL Platelets>=100,000/uL AST <=100 IU ALT <=100 IU T-Bil <=1.5 mg/dL eGFR >=60 PaO2 >=60 torr or SpO2 >=90% 7.A life expectancy of more than three months 8.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Interstitial pneumonia or pulmonary fibrosis detectable on chest radiograph. 2.Massive pericardial, pleural effusion or ascites 3.SVC syndrome 4.Symptomatic brain metastasis 5.Active concomitant malignancy 6.Uncontrollable diabetes mellitus or hypertension 7.Liver cirrhosis 8.Myocardial infarction within 6 months, unstable angina, those who received PTCA or CAGB within 6 months, congestive heart failure, uncontrollable arrhythmia 9.Pregnant or lactating women or those who declined contraception. 10.Severe drug allergy 11.Acute inflammatory diseases 12.Refusal against blood transfusion or other supportive therapies 13.Evidence of bleeding diathesis 14.Active infection 15.Those judged to be not suitable by the attending physician 16.Planning of thoracic radiotherapy during the trial.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD) of TS-1 and Nedaplatin	—

Secondary

Measure	Time frame
response rate	—

Countries

Japan

Contacts

Public ContactMisato Okamura

National Hospital Organization, Kyoto Medical Center Pulmonary Medicine

075-641-9161

Outcome results

None listed

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