A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)

A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705) - A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000896

Enrollment

Registered

2007-12-01

Start date

2007-11-01

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

Non-small cell lung cancer

Interventions

Chemotherapy S-1 (60 mg/m2, days 1-14, every 3 weeks) Gemcitabine (1,000 mg/m2, days 8 and 15, every 3 weeks) at least 3 courses, until reaching PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically/cytologically proven non-small cell lung cancer. 2) Prior chemotherapy of 2 or less than 2 regimens. Post-operative adjuvant chemotherapy, induction chemotherapy and intra-thoracic installation of cytotoxic agents are not considered as a regimen. 3) Prior chemotherapy consisting of platinum agents in at least one regimen. 4) Relapse after and/or resistant (SD or PR) to prior chemotherapy. 5) Interval of more than 28 days from the last chemotherapy/radiotherapy. 6) Lesions evaluated with RECIST. 7) PS (ECOG) of 0-1. 8) Preserved organ functions as a) Hb >= 9.0 g/dL b) Neutrophils >= 2,000/mm3 c) Platelets >= 100,000/mm3 d) AST/ALT <= 2.5 x upper limit of the normal value e) T. Bil <= 2.0 mg/dL f) Serum creatinine <= 1.5 mg/dL g) Creatinine crearance >=50 ml/min h) PaO2 >= 70 torr 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Any contraindication for S-1 or gemcitabine. 2) Active concomitant malignancy. 3) Active infectious diseases. 4) Prior resection of primary tumor. 5) Interstitial pneumonia obviously presented by x-ray and/or clinical manifestations. 6) Experience of any pulmonary event during the previous chemotherapy. 7) Prior chemotherapy including any primidine analogue such as 5-FU, tegafur, UFT, S-1, capecitabine, gemcitabine and Ara-C. 8) Brain metastasis with symptoms or requirement of treatment. 9) Requirement of thoracic irradiation. 10) Pleural effusion, ascites or pericardial effusion requiring treatment. 11) Serious abnormalty in ECG. 12) Uncontrolled diabetes mellitus. 13) Women in regnancy, potential pregnancy, or breast feeding. Men willing to cause pregnancy. 14) Other inadequate conditions .

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Toxicity, Overall survival, Progression free survival, Subset analyses	—

Countries

Japan

Contacts

Public ContactKojima, Hiroyuki

Thoracic Oncology Research Group Secretariat office

NPOTORGHKojima@aol.com03-3722-5330

Outcome results

None listed

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