Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation

Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation - Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003653

Enrollment

Registered

2010-05-25

Start date

2010-05-01

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

Amrubicin (day1-3) + TS-1 (day1-14)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed non-small cell lung cancer 2)unresectable disease 3)EGFR mutation negative or unknown 4)Age: 20-69 years old 5)Life expectancy more than 12weeks 6)ECOG Perfomance status 0-1 7)Previous 1- regimen chemotherapy consisting of platinum 8)Interval of more than 28 days from the last chemotherapy or radiotherapy 9)preserved organ's function WBC>=4,000/mm3 Hemoglobin>= 10.0g/dl Platelet count>=100,000/mm3 Total serum bilirubin <=1.5 mg/dl GOT/GPT <90 IU/l Serum creatinine <=1.5mg/dl 10)Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: 1)patients previously treated with amrubicin and 5-FU derivative drugs 2)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case) 3)evident pericardial effusion 4)serious complications below uncontrollable angina pectoris, myocardial infarction within 3 months or heart failure uncontrollable diabetes uncontrollable hypertension severe infection 5)pulmonary fibrosis or interstitial pneumonitis evident 6)HB and HC virus carrier 7)now pregnant or lactation 8)difficult to perform or continue of this study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
over all survival, progression free survival and frequency of adverse events	—

Countries

Japan

Contacts

Public ContactShuji Murakami

Kanagawa Cancer Center Department of Thoracic Oncology

murakamis@kcch.jp045-391-5761

Outcome results

None listed

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