A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial

A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial - A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007242

Enrollment

Registered

2012-02-07

Start date

2012-01-01

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 (squamous cell carcinoma)

Interventions

Induction chemothrapy Carboplatin: AUC=5, day 1 TS-1: 80mg/m2, day 1-14 q4w, 4 cycles Maintenance chemotherapy TS-1 maintenance: 80mg/m2, day 1-14 q4w, Until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histological or cytological confirmed squamous cell lung carcinoma. 2) Patients with unresectable stageIIIb- IV or postoperative recurrence. 3) Over 20 yeas old, under 75 years old. 4) ECOG PS 0-1. 5) Patients have the prospective for surviving more than 3 months. 6) Patients who are able to take oral medication. 7) Adequate main organ and bone marrow function filled below criteria within 14 days before registration. 1. Leukocyte counts >= 4,000/mm3 <=12,000 /mm3 2. Neutrophil counts>=1,500 /mm3 3. Platelets >= 100,000 /mm3 4. Hemoglobin >=9.0 g/dL 5. Total bilirubin <= 1.5 mg/dL 6. AST and ALT <= 100 IU/L 7. PaO2 >= 60 Torr or SpO2 >= 90% 8. Serum creatinin clearance >= 60 ml/min (Cockcroft-Gault) 8) Patients providing written informed consent.

Exclusion criteria

Exclusion criteria: 1) Any previous first line treatment with radiotherapy (including chemo radiotherapy) 2) Administration contraindication to Carboplatin and S-1. 3) Severe complications, such as cardiac failure, renal failure, hepatic failure, hemorrhagic gastric or duodenal ulcer, ileus, and uncontrollable or insulin-treated diabetic. 4) Severe drug allergies or history of drug hypersensitivity 5) Symptomatic or apparent interstitial pneumonia/lung fibrosis on CT scan or X-ray image findings (Included positive suspicion or history of them). 6) Severe watery diarrhea 7) With active infection. Fever higher than 38 degrees celsius. 8) HBsAg positive patients 9) The brain metastases which require emergent treatment. 10) Patients with ascites, pleural or pericardial effusion requiring drainage. 11) Patients undergoing UFT or TS-1 adjuvant therapy. The case postoperative recurrence within 6 months after adjuvant therapy. 12) Active concomitant malignancy with disease-free duration to be within 3 years. 13) Required to continue Flucytosine (5- FC), phenytoin and warfarinpotassium. 14) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant. 15) The case that is judged to be inadequacy for this study

Design outcomes

Primary

Measure	Time frame
1-year survival rate	—

Secondary

Measure	Time frame
Progression free survival(PFS) Overall survival (OS) Objective response rate (ORR) Safety	—

Countries

Japan

Contacts

Public ContactNaoyuki Nogami, M.D., Ph.D

National Hospital Organization Shikoku Cancer Center Department of thoracic oncology and medicine

nnogami@shikoku-cc.go.jp089-999-1111

Outcome results

None listed

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