Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia

Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia - Phase II Trial of CBDCA + S-1 for NSCLC with IP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011046

Enrollment

Registered

2013-06-26

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

Six cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients 2)Incurable NSCLC with stage IIIB or stage IV 3)Patients with no prior chemotherapy or one year after adjuvant chemotherapy 4)Patients who have measurable lesion or evaluable lesion by RECIST 5)Age of 20 to 79 years old 6)ECOG PS 0-2 7)Patients with interstitial pneumonias 8)Patients with expected life for at 12 weeks 9)Patients who are able to take orally 10)Have adequate organ function within two week before study entry WBC>=4000/mm3 Neutrophil>=1500/mm3 Hemoglobin>=9.0g/dl Platelets>=100000/mm3 Total bilirubin>=1.5mg/dl AST/ALT<=100IU Creatinine<=1.2mg/dl Creatinine clearance>=60mL/min 11) Merit with the chemotherapy 12) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1) Patients with pleural or pericardial effusion ,or ascites. 2) Patients with active double cancer. 3)Patients with significant complications. 4)Patients with serious diarrhea. 5)Patients with active infection. 6)Patients with symptomatic brain metastasis. 7)Being treated with flucytosine, phenytoin,warfarin. 8)Uncontrolled psychiatric disease. 9) allergic more than and equal to grade3. 10)History of serious allergic reaction with S-1 or CBDCA. 11)Patients with pregnancy or lactation. 12)Patients with HIV,HBV 13)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
Progression Free Survival, Overall Survival, 1 year survival rate, Quality of Life, Adverse Event	—

Countries

Japan

Contacts

Public ContactSoji Kakiuchi

Tokushima University Hospital Department of Respiratory medicine and Rheumatology

kakiuchi@clin.med.tokushima-u.ac.jp+81-88-633-7127

Outcome results

None listed

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