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Phase II study of nab-paclitaxel for relapsed non-small cell lung cancer (NLCTG1302)

Phase II study of nab-paclitaxel for relapsed non-small cell lung cancer (NLCTG1302) - Phase II study of nab-PTX for relapsed NSCLC(NLCTG1302)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012343
Enrollment
65
Registered
2013-11-19
Start date
2013-09-01
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

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Non-small cell lung cancer proven by histology and/or cytology 2)EGFR mutation or ALK rearrangement status is not required 3)One or two prior cytotoxic chemotherapy 4)20 years or older 5)Performance Status 0-2 6)At least one or more measurable lesion by RECIST ver1.1 7)Adequate organ function 8)Life expectancy more than twelve weeks. 9)Written Informed Consent

Exclusion criteria

Exclusion criteria: 1)History of paclitaxel treatment 2)Severe complications 1:Type 2 DM treated with insulin injection 2:Symptomatic congestive heart failure or unstable angina or problematic arrhythmia or history of acute myocardial infarction within one year 3:Interstitial pneumonia or active radiation pneumonia or drug-induced pneumonia 3)Problematic infection 4)History of active double cancer 5)Severe drug allergy 6)No intention to birth control 7)Unstable psychic disorder 8)Decision of ineligibility by a physician.

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Safety, Progression free survival, Disease control rate, Overall survival, Evaluation of sensory neuropathy using PNQ score

Countries

Japan

Contacts

Public ContactSatoru Miura

Niigata University Medical & Dental Hospital Department of Medicine (II)

miusat1118@med.niigata-u.ac.jp025-227-2200

Outcome results

None listed

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