Skip to content

A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer

A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer - A phase I/II study of weekly nab-Paclitaxel/Cisplatin in NSCLC

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011776
Enrollment
35
Registered
2013-09-17
Start date
2013-10-01
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 80mg/m2, day 1,8,15 cisplatin 60mg/m2 day 1 every 4 weeks Level 1
nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks Level 2
nab-paclitaxel 100mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks

Sponsors

Hyogo Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery 3)EGFR mutation negative, ALK rearrangement negative, other driver oncogenes negative 4)Age: 20- years old 5)ECOG PS 0-1 6)With measurable lesion 7)Adequate organ function 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)History of severe drug allergy 3)EGFR mutation positive, ALK rearrangement positive, other driver oncogenes positive 4)History of serious disease condition 5)Symptomatic brain metastasis 6)History of active double cancer 7)History of pregnancy or lactation 8)History of active psychological disease

Design outcomes

Primary

MeasureTime frame
objective response rate

Secondary

MeasureTime frame
progression free survival, overall survival, toxicity

Countries

Japan

Contacts

Public ContactYoshihiro Hattori

Hyogo Cancer Center Department of Thoracic Oncology

hattori@hp.pref.hyogo.jp078-929-1151

Outcome results

None listed

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