Phase II study of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy in patients with unresectable locally advanced non-small cell lung cancer

Phase II study of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy in patients with unresectable locally advanced non-small cell lung cancer - Phase II study of ABI + CBDCA + TRT for unresectable LA-NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011681

Enrollment

Registered

2013-09-09

Start date

2013-09-09

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

Non-small cell lung cancer

Interventions

Chemoradiotherapy nab-paclitaxel:Nab-paclitaxel is administered intravenously at a dose of 40mg/m2 on days 1,8,15,22,29,36. carboplatin:Carboplatin is administered intravenously at a dose of AUC2 on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-small cell lung cancer. 2)Unresectable clinical stage IIIA or IIIB. 3)Over 20 years at registration. 4)ECOG Performance Status(PS) of 0 or 1. 5)At least one measurable lesion. 6)Patients with no previous treatment(radiotherapy, chemotherapy etc) for non-small cell lung cancer. 7)Sufficient function of major organs as defined below. White blood cell count>=4,000 /mm3 Neutrophil count>=2,000 /mm3 Platelet count>=100,000 /mm3 Hemoglobin>=9.5 g/dL Total bilirubin<=1.5 mg/dL AST and ALT<=100 U/L Serum creatinine<=1.2 mg/dL PaO2>=70 torr 8)Voluntarily signed the written consent form.

Exclusion criteria

Exclusion criteria: 1)Active double cancer. 2)Active infections requiring systemic treatment. 3)Serious complications(e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes) 4)Grade2 or higher peripheral neuropathy. 5)Positive HBs antigen and/or HCV antibody. 6)History of severe drug allergy. 7)History of hypersensivity for albumin-containing agents. 8)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers.Males that are currently attempting to produce a pregnancy. 9)Judged ineligible by physicians for participation in the study from a safety viewpoint.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Incidence and Severity of Adverse Events Treatment completion rate of Chemoradiotherapy Progression free survival Overall survival	—

Countries

Japan

Contacts

Public ContactTakaaki Hasegawa

Gifu Municipal Hospital Department of respiratory and medical oncology

takaaki_hase@bird.ocn.ne.jp058-251-1101

Outcome results

None listed

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