Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer

Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer - Phase1/2 study of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000439

Enrollment

Registered

2006-07-01

Start date

2006-07-01

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

Preaviously untreated advanced advanced squamous cell lung cancer

Interventions

Combination chemotherapy with gemcitabine and nedaplation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Squamous cell lung cancer 2) Measurable lesions 3) Preaviously untreated advanced squamous cell lung cancer 4) PS(ECOG)0-1 5) Adequate organ fanctions 6) A life expectacy of at least 3 months 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Interstitial pneumonia or pulmonary fibrosis on chest X-P 2) peural or pericardial effusion requiring drainage 3) SVC syndrome 4) Symptomatic brain metastases 5) Active concominant malignancies 6) Uncontrolled diabetes mellitus or hypertension 7) Liver cirrhosis 8) Severe cardiovascular diseases 9) Pregnancy and lactation 10) Ccr<60ml/min 11) A history of serious drug allergy 12) Acute infection 13) Bleeding tendency 14) Unsuitable for entry to the study, decided by a medical oncologist

Design outcomes

Primary

Measure	Time frame
Recommended dose Dose limmiting toxicity Response Rate	—

Secondary

Measure	Time frame
Overall survival Time to progression Toxicity	—

Countries

Japan

Contacts

Public ContactKatsuhiro Masago

Kyoto unversity hospital Department of Respiratory Medicine

mio@kuhp.kyoto-u.ac.jp075-751-3830

Outcome results

None listed

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