Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC

Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC - Phase II clinical study of nab-PTX/CBDCA for patients with clinical stage IIIB/IV or recurrent NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016255

Enrollment

Registered

2015-01-19

Start date

2015-01-19

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

lung cancer

Interventions

nab-Paclitaxel (100mg/m2) day 1,8,15 + CBDCA (AUC 6 ) day 1 : every 4 weeks (administer 3-weeks on / 1-week off) 4cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed nonsmall cell lung cancer. 2.clinical stage IIIB/IV or postoperative recurrence. 3.At least one mesurable lesion according to RECISTversion1.1. 4.Chemotherapy-naive patients or postoperative patients without adjuvant chemotherapy until 6 months before the registration. 5.With adequate organ function 5-1.neutrophil count => 1,500/mm^3 5-2.platelet => 100,000/mm^3 5-3.hemoglobin => 9.0g/dL 5-4.AST/ALT <= 2.5 times less than ULN 5-5.T.Bil <= 1.5mg/dL 5-6.serum creatinine <= 1.5mg/dL 5-7.Peripheral neuropathy <= Grade 1 6.Life expectancy of at least 3 months 7.ECOG performance status 0 or 1 8.With written informed consent

Exclusion criteria

Exclusion criteria: 1.With severe myelosuppression. 2.With the history of hypersensitivity for nab-paclitaxel or CBDCA. 3.With active double cancer. 4.With active infectious disease:temperature=>38 5.With clinically important complications. 6.Interstitial pneumonia or pulmonary fibrosis on chest X-rays. 7.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 8.Accepted continuous use of steroid. 9.Physician concludes that the patient's participation in this trial is inappropriate.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression free survival/overall survival/disease control rate/adverse events/completion rate of treatment	—

Countries

Japan

Contacts

Public ContactJun Hanaoka

Shiga University of Medical Science Department of thoracic surgery

hanaoka@belle.shiga-med.ac.jp077-548-2244

Outcome results

None listed

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