Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer

Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer - Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016765

Enrollment

Registered

2015-03-11

Start date

2011-10-01

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

EGFR-mutated non-small cell lung cancer

Interventions

To evaluate safety and efficacy of the combination of vinorelbine and TS-1 in patients with EGFR-mutated non-small cell lung cancer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Histological or cytological diagnosis of non-small cell lung cancer 2 Unresectable 3 Have measurable lesions 4 No prior chemotherapy excluding gefitinib or elrotinib 5 EGFR mutation (including T790M)-positive 6 ECOG Performance Status (PS) 0 to 1 7 Life expectancy of more than three months 8 patients aged 20 years or older 9 Have adequate function of major organs (bone marrow, liver, kidneys) defined as follows (1)White blood cell >= 4,000/mm3 (2)Neutrophils >= 2,000/mm3 (3)Hemoglobin >=10.0g/dl (4)Platelets>=100,000/mm3 (5)Total bilirubin<=1.5mg/dl (6)AST(GOT) <=2xULN (7)ALT(GPT) <=2xULN (8)creatinine clearance >= 60ml/min (9)PaO2>= 60mmHg 10 Oral intake 11 Normal electrocardiogram 12 Provided written consent in person for participation in this study

Exclusion criteria

Exclusion criteria: 1 Patient with need of procedure for pleural effusion 2 Patient with need of drainage procedure for cardiac effusion 3 Patient with symptomatic brain metastasis 4 Patient with severe complications5 5 Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray 6 Female Patient in or having a chance or planning of pregnancy or breast feeding 7 Male patient in planning to impregnate 8 Patient with active multiple cancers 9 Patients with history of drug hypersensitivity 10 Patients with histoly of hypersensitivity against vinorelbine or other vinca alkaloids 11 Patients with histoly of hypersensitivity against TS-1 or pyrimidine fluoride 12 Being treated with other pyrimidine fluoride 13 Being treated with flucytosine 14 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
Disease control rate, Overall survival, Response rate, Safety	—

Countries

Japan

Contacts

Public ContactTadashi Igishi

Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology

igishi@med.tottori-u.ac.jp0859-38-6537

Outcome results

None listed

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