Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung.

Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung. - Randomized phase II study of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012903

Enrollment

Registered

2014-02-01

Start date

2014-01-06

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

squamous cell carcinoma of the lung

Interventions

nab-PTX plus CBDCA followed by maintenance nab-PTX. TS-1 plus CBDCA followed by maintenance TS-1.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed squamous cell lung cancer. 2.Stage IIIB/IV without indication for radical thoracic irradiation or postoperative recurrence. 3.No prior chemotherapy or postoperative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy. 4.Age > or = 20 years 5.Eastern Cooperative Oncology Group performance status of 0-1 6.Tumor has the Measurable lesion. 7.Adequate organ function, Adequate organ function within 2 weeks 7-1:Leukocyte count > or = 3,000/mm3 7-2:Neutrophil count > or = 1,500/mm3 7-3:Hemoglobin > or = 9.0 g/dl 7-4:Platelet count > or = 100,000/mm3 7-5:Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L 7-6:Total bilirubin < or = 1.5 mg/dl 7-7:Serum creatinine < or = 1.2 mg/dl 7-8:Creatinine clearance; > or = 60mL/min 7-9:Acceptable cardiac function 7-10:Peripheral neuropathy < or = grade 1 8.Estimating Survival more than 3 months. 9.Capable of oral intake 10.Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to drugs or albumin. 2.Severe infection 3.Significant comorbid disease (paresis of intestine, ileus, GI bleeding, uncontrolled angina pectoris, cardiac disease, etc) 4.Massive pleural and cardiac effusion and ascites required for tube drainage. 5.Cases of administration in the flucytosine. 6.Patients with superior vena cava syndrome. 7.Active synchronous malignant neoplasm. 8.Interstitial pneumonia or pulmonary fibrosis detectable on Chest X ray. 9.Brain metastases patients in need of treatment, such as an anti-seizure medication and steroids or have symptoms. 10.Cases of post-radiation to the primary tumor. 11.Cases of palliative bone or brain irradiation within two weeks of proposed entry to this study. 12.Uncontrolled psychiatric disease. 13.Pregnancy, breast feeding and suspected pregnancy. 14.Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
progression free survival(PFS)	—

Secondary

Measure	Time frame
quality of life(QOL) response rate(RR) disease control rate(DCR) overall survival(OS) maintenance therapy shift rate PFS from the start of maintenance therapy adverse events(AEs)	—

Countries

Japan

Contacts

Public ContactSeisuke Nagase

Internationanl University of Health and Welfare Respiratory Disease center

snagase@iuhw.ac.jp03-3451-8121

Outcome results

None listed

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