Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer

Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer - Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011663

Enrollment

Registered

2013-09-05

Start date

2013-09-05

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

Unresectable locally advanced non-small cell lung cancer

Interventions

Level0 CBDCA :AUC4(day1)+ S-1:50mg/m2(day1-14)+ RT 2Gy * 5days/week (total: 60Gy) q4weeks Level1 CBDCA :AUC5(day1)+ S-1:50mg/m2(day1-14)+ RT 2Gy * 5days/week (total: 60Gy) q4weeks Level2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with histlogically or cytologically confirmed non-small cell lung cancer 2)Patients with clinical unresectable stage IIIA or IIIB 3) 20<=, <75 years old 4)ECOG Performance status 0-1 5) Expected survival more than 3 months 6)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors 7)No prior chemotherapy nor radiation therapy 8)Adequate bone marrow reserve and organ function 9)Written IC

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 allergic reaction with CBDCA or other platinum-containing drug 8) History of serious allergic reaction with S-1 9) Being treated with other pyrimidine fluoride antineoplastic agents. 10) Being treated with flucytosine. 11) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Phase I study: MTD, RD Phase II study : Response rate in RD	—

Secondary

Measure	Time frame
Phase I study: Safety, RR Phase II study : OS, PFS and Safety	—

Countries

Japan

Contacts

Public ContactYoshiki Ishii

Dokkyo Medical University Department of Pulmonary Medicine and Clinical Immunology

ishiiysk@dokkyomed.ac.jp0282-87-2151

Outcome results

None listed

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