First-line trial of CBDCA + S-1 + Gefitinib for patients with advanced or reccurent NSCLC patients harboring activating mutation of the EGFR gene -Phase II trial-

First-line trial of CBDCA + S-1 + Gefitinib for patients with advanced or reccurent NSCLC patients harboring activating mutation of the EGFR gene -Phase II trial- - Phase II trial of CBDCA + S-1 + Gefitinib

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005503

Enrollment

Registered

2011-05-01

Start date

2011-05-01

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

CBDCA + S1 + Gefitinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) diagnosis of NSCLC 2) advanced (stage IIIB who can not treat radiation therapy, and stage IV) or reccurent NSCLC patients 3) the patients who have the target region for RECIST v1.1 4) harboring activating mutation of EGFR gene (exon 19 delation, and L858R) 5) non perior chemotherapy, or 1 year or more after adjuvant chemotherapy 6) 20 years old or more 7) PS 0-1 8) good condition of main organ 9) over 12 weeks of lifetime expectancy 10) agreement of informed concent for this trial

Exclusion criteria

Exclusion criteria: 1) the patients who have interstitial change. 2) allergy of the medication 3) double cancer 4) un-controled pleural effusion and ascites 5) severe conplications, including AMI, un-controled angina pectoris, and un-controled diabetis and hypertension 6) synptomatic brain metastasis 7) radiation therapy which has thoracic field 8) the patients who treat with flucytosine 9) the case of pregnancy and lactation 10) the doctors' jundgement of expurgate

Design outcomes

Primary

Measure	Time frame
The rate of one year progression free survival (1 year PFS rate)	—

Secondary

Measure	Time frame
response rate progression free survival (PFS) overall survival (OS) safety	—

Countries

Japan

Contacts

Public ContactAkihiro Tamiya

National hospital organization Kinki-Chuo Chest Medical Center thoracic oncology

atamiya@kch.hosp.go.jp072-252-3021

Outcome results

None listed

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