A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402

A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402 - A phase I/II Study of CBDCA+TS-1 in Non-small Cell Lung Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000234

Enrollment

Registered

2005-11-24

Start date

2005-02-01

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

Advanced non-small cell lung cancer

Interventions

Carboplatin and TS-1 chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologycally or cytologically proven non-small cell lung cancer 2. Stage IIIB with no indication of radiation therapy, and Stage IV 3. Measurable by RECIST critelia in phase II portion. 4. Age over 19 years-old, and less than 75 years-old. 5. ECOG Performance Status of 0 or 1 6. Chemo-naive 7. Post-operative or asymptomatic brain metastasis or radiation therapy to the non-target lesion is allowed. 8. Adequate bone marrow, liver, and renal functions WBC > 4,000 /uL Neutro > 2,000 /uL Platlets > 100,000 /uL Hb > 9.5 g/dL s-Cr 30 mL/min AST, ALT 60 mmHg or SpO2 > 90% 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Massive pleural effusion with the incication of local therapy 2. Clinically appearent pericardial effusion 3. Serious medical complications: Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infections. Contraindication for carboplatin or TS-1 use 4. Pulmonary fiblosis detectable on chest X-ray films 5. Pregnant or milk-feeding female. Intention to be pregnant in the future 6. Other clinical difficulites to this study

Design outcomes

Primary

Measure	Time frame
Phase I: Safety, maximum tolerated doses, recommended doses Phase II: Response rate	—

Secondary

Measure	Time frame
Phase I: Response rate Phase II: Safety, survival time	—

Countries

Japan

Contacts

Public ContactHideo Saka, M.D.

National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine

saka@nagoya.hosp.go.jp+81-52-951-111

Outcome results

None listed

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