A phase I/IItrial of TS-1 and nab-pacliaxel for advanced non-small cell lung cancer

A phase I/IItrial of TS-1 and nab-pacliaxel for advanced non-small cell lung cancer - A phase I/IItrial of TS-1 and nab-pacliaxel for advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013612

Enrollment

Registered

2014-04-03

Start date

2014-04-02

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

Chemotherapy: Combination of TS-1 plus nab-paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cytologically or histologically documented non-small cell carcinoma of the lung that is not for curable thoracic radiotherapy. 2) Previously treated Stage IIIB orIV and had a maximum of two regimen 3) Previously treated Stage IIIB or IV by not paclitaxel(nab-PTX)and TS-1 4) Patient more than 19 years old at the time of consent. 5) Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1 Have measurable lesion 6) Have adequate swallowing function 7)Have measurable and unmeasurable lesion 8)Have adequate organ function within two week before study entry 9)Have capacity of survival more than 12 weeks after study entry 10)Have capacity of prevention pregnancy while duration of from study entry to final medication after 3 months 11) Have signed an informed consent document

Exclusion criteria

Exclusion criteria: 1) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease,)confirmed by chest CT scan. 2) Previously treated by thoracic radiation within 4weeks 3) Patients with flucytosine treatment. 4) SVC syndrome 5) Clinically significant drug allergy 6) Uncontrolled pleural effusion and pericardial effusion 7) Severe heart disease, myocardial infarction in the past 6 months,uncontrolled hypertension activeinfection,severe complication(entero bleeding etc) 8) Continuous diarrhea 9) Paresis of intestine and ileus 10) Brain metastasis with symptomatic 11) With active double cancer. 12) Uncontrolled diabetes mellitus. 13) Uncontrolled psychiatric disease. 14) Pregnancy or lactating patients 15) Others

Design outcomes

Primary

Measure	Time frame
Primary endpoints:determing recommended dose	—

Secondary

Measure	Time frame
Secondary Endpoints:safety,parameter of pharmacokinetics of chemotherapy with TS-1 plus nab-paclitaxel ,completion duration of chemotherapy,overall survival, response rate	—

Countries

Japan

Contacts

Public ContactYoshitaro Torii

Kansai Medical University Hirakata Hospital Department of Thoracic Oncology

toriiy@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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