A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung

A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung - A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006433

Enrollment

Registered

2011-11-01

Start date

2011-11-01

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

adenocarcinoma of the lung

Interventions

S-1 after gefitinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. adenocarcinoma of the lung was confirmed cytological or pathological examiation. 2. TR is possible for cytological or pathological examination at the entry (relapse after gefitinib monotherapy) 2. stage IV and reccurent cases after resection. 3. age 20-80 years 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5. tumor with negative or unkown for EGFR senstive mutation. 6. CR, PR, and SD cases after gefitinib monotherapy

Exclusion criteria

Exclusion criteria: they had a concurrent malignancy, uncontrollable complications, severe morbidity; hypersensitivity to therapeutic agents; the possibility of being pregnant, and other conditions such as hepatic inflammation, as judged by the attending physician.

Design outcomes

Primary

Measure	Time frame
PFS	—

Secondary

Measure	Time frame
RR (gefitinib+S-1), OS, AE, and association between resistant related molecules and clinical effect	—

Countries

Japan

Contacts

Public Contactkoushi kuroda

University of Occupational and Environmental Health Second Department of Surgery

kuroda-k@med.uoeh-u.ac.jp0936917442

Outcome results

None listed

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