Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302)

Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302) - Assessment of efficacy and safety of CDDP+GEM followed by GEM in advanced squamous cell lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010721

Enrollment

Registered

2013-05-15

Start date

2013-05-15

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

squamous cell lung cancer

Interventions

Induction chemotherapy(4 courses) Gemcitabine(GEM):1000mg/m2, day1,8 Cisplatin(CDDP):80mg/m2, day1 contunuation meintenance chemotherapy(until PD) Gemcitabine(GEM):1000mg/m2 day1,8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically proven squamous cell lung cancer 2) No prior chemotherapy for squamous cell lung cancer or one year after operation or adjuvant chemotherapy 3) Age 20 to 75 years 4) Performance status(ECOG) 0 or 1 5) Measurable disease according to RECIST ver 1.1 6) Sufficient organ functions 7) Life expectancy of more than 3 months 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with histologically proven non-squamous cell lung cancer 2) Recognized ILD or pulmonary fibrosis on X-rays 3) Pleural effusion, peritoneal fluid and pericardial fluid that need treatment 4) Superior vena cava syndrome 5) Symptomatic brain metastasis 6) Active concomitant malignancy 7) Prior therapy with gemcitabine 8) Diabetes and hypertension that cannot be controlled 9) Liver cirrhosis 10) Symptomatic or asymptomatic but treated heart disease 11) Severe infectious disease 12) Pregnant women, possibly pregnant women, wishing to become pregnant 13) Serious drug hypersensitivity or a history of drug allergy 14) Refusal of supportive care such as blood transfusion 15) Bleeding tendency 16) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall survival Safety response rate	—

Countries

Japan

Contacts

Public ContactSatoshi Ikeda

Kurashiki Central Hospital (Ohara HealthCare Foundation) Department of Respiratory Medicine

si13546@kchnet.or.jp086-422-0210

Outcome results

None listed

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