A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer

A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer - A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016730

Enrollment

Registered

2015-03-07

Start date

2014-09-01

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

Locally Advanced Non-Small Cell Lung Cancer

Interventions

Chemoradiotherapy: Combination of weekly carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for a total 60Gy at 2Gy/fraction/day 5times weekly for 30 times. Consolidation ther

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Cytologically or histologically confirmed non-small-cell lung cancer 2)Unresectable locally advanced non-small-cell lung cancer (stage III) 3)When radio-oncologist judged that the patients can tolerable for full dose irradiation 4)No prior chemotherapy and thoracic radiotherapy 5)At least one measurable lesion 6)Aged 75 or more 7)ECOG Performance status of 0-1 8)Sufficient major organ function 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 2)V20 exceed 35% 3)Patients with opposite hilar lymph nodes metastases, or massive pleural or pericardial effusion 4)Patients with active double cancer 5)Patients with serious disease condition (severe infections,diarrhea,ileus,poorly controlled diabetes, unstable angina,cardiac infarction within 6 months before enrollment,severe heart failure, etc.) 6)Severe emphysema, chronic bronchitis, asthma 7)Postoperative relapse 8)History of drug-induced pneumonia or severe drug allergies 9)History of hypersensitivity to albumin preparations 10)Grade 2 or higher peripheral neuropathy 11)Patients with severe mental illness 12)HBs antigen positive, or HBV-DNA positive ( HBs antigen negative but HBs antibody or HBc antibody positive) 13)Unsuitable patients judged by the attending physician

Design outcomes

Primary

Measure	Time frame
phase I:determine the recommended dose phase II:response rate	—

Secondary

Measure	Time frame
phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy,2year survival rate phase II:safety, progression free survival, overall survival, completion rate of chemoradiotherapy,2year survival rate	—

Countries

Japan

Contacts

Public ContactNobuyuki Katakami

Institute of Biomedical Research and Innovation Division of Integrated Oncology

katakami@fbri.org078-304-5200

Outcome results

None listed

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