Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer

Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer - Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012505

Enrollment

Registered

2013-12-06

Start date

2013-08-01

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

Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks and repeated 4 course.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically proven non-small cell lung cancer, except for low-malignant potential tumor such as mucoepidermoid carcinoma or adenoid cystic carcinoma, and large cell neuroendocrine carcinoma. 2) Pathological stage IB squamous cell lung cancer or stage II, IIIA non-small cell lung cancer 3) With complete resection 4) At least lobectomy (tracheobronchoplasty is permitted) 5) LN dissection (ND2a) or Elective Lymph Node Dissection 6) No prior anti-cancer treatment for thoracic malignancy except for this operation 7) ECOG PS 0-1 8) More than 20 years of age, under 75 years of age 9) Adequate organ function *Neutrophil count => 1,500/&micro;L *Platelet => 100,000/&micro;L *Hemoglobin => 9.0g/dL *AST/ALT < 2.5 times less than ULN *T.Bill <= 1.5mg/dL *Serum creatinine = 1.5mg/dL *ECG: without clinically problematic abnormalities 10) Within 10 weeks after surgery 11) With written informed consent

Exclusion criteria

Exclusion criteria: 1) Not recovered from surgical complications 2) Active infection such as bacterial infection 3) Patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infraction within 6 months 5) Patients with uncontrolled complications 6) With the history of hypersensitivity for nab-paclitaxel or CBDCA 7) Grade 2 or greater peripheral neuropathy 8) Active concomitant malignancy 9) Pregnant females, nursing mothers, possibly pregnant females, females wishing to become pregnant and Males that are currently attempting to produce a pregnancy 10) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
The completion rate	—

Secondary

Measure	Time frame
toxicities, disease-free survival, overall survival, recurrence type	—

Countries

Japan

Contacts

Public ContactMasayuki Chida

Dokkyo Medical University Thoracic Surgery

chidaths@dokkyomed.ac.jp0282-86-1111

Outcome results

None listed

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