A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer

A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer - A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010189

Enrollment

Registered

2013-03-07

Start date

2013-04-01

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

CBDCA AUC:5 d1 q4w until PD TS-1 was administered at fixed dose 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 d1-14 q4w until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer (2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery (3)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors (4) Age:20-74years old (5)ECOG performance status of 0 to 1 (6)With ability of oral intake (7)Adequate organ function, evaluated within 14 days before enrollment (8)Expected to live over 3 months after administration days. (9)Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray 2)Patients with pleural or pericardial effusion ,or ascites 3) Patients with active double cancer 4)Patients with significant complications a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella) 5)Patients with symptomatic brain metastasis 6)Patients with pregnancy or lactation 7) History of serious drug allergy 8) History of serious allergic reaction with CBDCA or other platinum-containing drug 9) History of serious allergic reaction with S-1 10) Being treated with other pyrimidine fluoride antineoplastic agents. 11) Being treated with flucytosine. 12) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Overall survival, Progression free survival 1-year survival Rate, Safety	—

Countries

Japan

Contacts

Public Contactogawara mitsumasa

National Hospital Organization Osaka Department of Respiratory Medicine

ogawaram@onh.go.jp06-6942-1331

Outcome results

None listed

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