Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.

Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer. - Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010963

Enrollment

Registered

2013-06-17

Start date

2013-06-17

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

Level 0 nedaplatin : 100mg/m2(day1)+ nab-paclitaxel: 60mg/m2(day1,8,15) q4weeks Level 1 nedaplatin : 100mg/m2(day1)+ nab-paclitaxel: 80mg/m2(day1,8,15) q4weeks Level 2 nedaplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer. 2) Clinical stage IIIB, IV or recurrent disease after surgery. 3) No prior chemotherapy. No adjuvant chemotherapy within 1 years. 4) Age: 20 to 74 5) ECOG performance status of 0 or 1. 6) With at least one or more measurable lesion by RECIST. 7) Adequate organ function. 8) Life expectancy more than 3 months. 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Severe infection. 2) Severe complications. 3) Uncontrollable pleural or pericardial effusion or ascites. 4) Superior vena cava syndrome. 5) Simultaneous or metachronous double cancers. 6) Symptomatic brain metastases. 7) Prior radiotherapy for primary tumor. 8) Radiotherapy other than primary tumor within 2 weeks. 9) A history of serious drug allergy or severe allergic reaction with albumin. 10) Psycologic illness

Design outcomes

Primary

Measure	Time frame
Finding a decomending dose	—

Secondary

Measure	Time frame
evaluation of safety and response rate	—

Countries

Japan

Contacts

Public ContactSatoshi Igawa

Kitasato University School of Medicine Department of Respiratory Medicine

igawa@kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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