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Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer

Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer - Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035812
Enrollment
45
Registered
2019-02-08
Start date
2011-11-12
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

S1 is administered orally twice daily for 14 days a day, according to the body surface area, followed by 7 days off. PTX 80 mg / m 2 is administered on Day 1, 8 by drip infusion. One cycle is 21 days.

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A case in which definitive diagnosis of non-small cell lung cancer was obtained by histology or cytology 2) Cases with measurable lesions 3) Patients with a history of chemotherapy treatment containing 1 platinum regimen over 1 regimen (treatment history of surgical therapy and radiotherapy is not limited) 4) Cases with 4 weeks or more have passed since the end of previous chemotherapy 5) Case of over 20 years old 6) Case of Performance Status 0-1 of ECOG 7) Cases with sufficient bone marrow function and organ function 8) Cases in which survival for more than 2 months can be expected 9) Cases with oral administration 10) Case informed consent obtained document from patient himself

Exclusion criteria

Exclusion criteria: 1: Cases with serious complications Interstitial pneumonia Serious heart disease diabetes which is difficult to control Serious infectious diseases 2: Cases with other active organs and overlapping cancers 3: Patients with a history of severe hypersensitivity 4: Case in which flucytosine is being administered 5) Cases with a history of alcohol hypersensitivity

Design outcomes

Primary

MeasureTime frame
Overall response rate

Secondary

MeasureTime frame
Progression-free survival Overall survival safety

Countries

Japan

Contacts

Public ContactYusuke Chihara

Kyoto Prefectural University of Medicine Department of Pulmonary Medicine

c1981311@koto.kpu-m.ac.jp075-251-5513

Outcome results

None listed

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