The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more

The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more - The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023763

Enrollment

Registered

2016-08-25

Start date

2014-12-01

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 or recurrent non-small cell lung cancer

Interventions

weekly nab-Paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Non-small cell lung cancer with cytological (except sputum cytology) or histologically diagnosis. 2.There is a chemotherapy treatment history of 2 or 3 regimen that includes a platinum doublet therapy and docetaxel single agent therapy. In addition, it does not count as one regimen for EGFR-TKI and ALK inhibitor. However, erlotinib for EGFR gene mutation with wild type to count as 1 regimen. In addition, for patients who relapsed within 6 months from adjuvant chemotherapy last administration day, it counted as one regimen the last dose regimen of adjuvant chemotherapy. 3.It has been passed after 2 weeks or more from radiation therapy. 4.Cases with measurable lesions. 5.Age cases of more than 20 year old 6.ECOG Performance status (PS) 0-2. 7.Major organ function (bone marrow, heart, liver, kidney, etc.) is satisfaction on registrationin date from 14 days. The number of neutrophils: >= 1,500 /mm3 Hemoglobin value: >= 8.5 g/dL Platelet count : >= 100,000/mm3 AST value, ALT values: <= 100 IU/L Total bilirubin: <= 1.5 mg/dL Serum creatinine values: <= 1.5mg/dL Cardiac function: No abnormal findings it becomes clinical problem Peripheral neuropathy: <= Grade1 Respiratory function: SpO2: 90% or more 8.Patients can be expected survival from three months or more after treatment started. 9.Patient has agreed for participation in this study in writing.

Exclusion criteria

Exclusion criteria: 1.Patients with paclitaxel treatment history. 2.Patients with hypersensitivity to paclitaxel or preparations containing albumin. 3.Patients with active double cancer in need of treatment. However it is not excluded that carcinoma in situ that is judged to be healing by local treatment, intramucosal cancer equivalent of lesions or other cancers unlikely in need of treatment. 4.The infection requiring systemic treatment (including patient of HBs antigen-positive). 5.Serious complications (heart disease, interstitial pneumonia, uncontrolled high blood pressure or diabetes, etc.) 6.there is a possibility of pregnancy or during pregnancy or lactating women. 7.Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial. 8.Patients during systemic administration steroids therapy(oral or intravenous). 9.Patients with symptomatic brain metastases. 10.Other, cases physicians it is judged unsuitable for registration of this clinical trial.

Design outcomes

Primary

Measure	Time frame
Disease Control Rate	—

Secondary

Measure	Time frame
Response Rate, Overall survival, Progression free survival, Time to Treatment Failure, Adverse events (adverse reactions) occurrence rate	—

Countries

Japan

Contacts

Public ContactTakeshi Honda

Department of Internal Medicine Teikyo University School of Medicine Division of Medical Oncology

thonda@med.teikyo-u.ac.jp+81-3-3964-1211

Outcome results

None listed

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