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Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy.

Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy. - Phase II study of nedaplatin plus docetaxel in patients with advanced squamous cell lung cancer pretreated with platinum-based chemotherapy.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003883
Enrollment
28
Registered
2010-07-07
Start date
2010-06-01
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

relapsed squamous cell lung cancer

Interventions

Nedaplatin(80mg/m2/day) and Docetaxel(60mg/m2/day)on day1, every 3 weeks

Sponsors

Shizuoka Cancer Center, Thoracic Oncology Division
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically or cytologically confirmed squamous cell lung cancer 2) received one prior chemotherapy or chemo-radiotherapy with platinum-based regimen 3) no prior treatment with nedaplatin or docetaxel 4) refractory or relapsed and measurable disease 5) performance status of 0-1 on the Eastern Cooperative Oncology Group scale 6) age from 20 to 74 years 7) adequate organ function 8) written informed consent

Exclusion criteria

Exclusion criteria: 1) interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2) symptomatic brain metastasis 3) steroid treatment 4) massive pleural effusion or pericardial effusion 5) active infection 6) history of active double cancer 7) history of severe drug allergy 8) uncontrollable diabetes mellitus 9) HBs antigen 10) history of pregnancy or lactation 11) history of active psychological disease 12) severe drug allergy for 80 polysorbate content medicine 13) any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
overall survival, progression-free survival, adverse events

Countries

Japan

Contacts

Public ContactHaruyasu Murakami

Shizuoka Cancer Center Shizuoka Cancer Center, Thoracic Oncology Division

ha.murakami@scchr.jp055-989-5222

Outcome results

None listed

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