Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.

Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer. - Phase II clinical study of nab-PTX for patients with recurrent NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016932

Enrollment

Registered

2015-03-26

Start date

2015-04-01

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

advanced non-small cell lung cancer

Interventions

Arm A nab-Paclitaxel (100mg/m2) day 1,8,15 : every 4 weeks Arm B nab-Paclitaxel (70mg/m2) day 1,8,15 : every 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer. 2) Clinical stage IIIB, IV or post-operative recurrence. 3) Age 20 years or older. 4) ECOG Performance Status (PS) 0 to 1. 5) At least one mesurable lesion according to RECIST version 1.1. 6) Patients treated with at least one platinum regimens 7) With adequate organ function, neutrophil count over 1,500 / mm3, hemoglobin concentration over 9.0 g / dL, platelet count over 100,000 / mL), kidney (creatinine within 1.5 mg / dL), liver (AST/ALT within 2.5 times less than ULN, total bilirubin within 1.5 mg/dL), peripheral neuropathy within Grade1, PaO2 over 60 Torr or SpO2 over 94. 8) Life expectancy of more than three months. 9) Provided written consent in person for participation in this study.

Exclusion criteria

Exclusion criteria: 1) Patient with previous treatment by paclitaxel. 2) Patient receiving chemotherapies less than 4 weeks or EGFR-TKI within two weeks. 3) Patient receiving definitive radiotherapy for less than 6 weeks or local palliative radiotherapy for less than 2 weeks. 4) Patient with symptomatic brain metastasis. 5) Patient with need of chest drainage for pleural effusion. 6) Active infection. 7) Patient with severe complications. 8) Patient having autoimmune disease to need treatment by the immunosuppressive drug. 9) Patient with active multiple cancers. 10) Female Patient in or having a chance or planning of pregnancy or breast feeding. Male patient in planning to impregnate. 11) History of sever psychological disease. 12) Administering steroid. 13) Any patients judged by the investigator to be unfit to participate in the study.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall survival/ Objective response rate/ Adverse events	—

Countries

Japan

Contacts

Public ContactKaoru Kubota

Nippon Medical School Hospital Cancer center and Department of Pulmonary Medicine and Oncology

kkubota@nms.ac.jp03-3822-2131

Outcome results

None listed

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