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Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS.

Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS. - Phase II trial of irinotecan, paclitaxel plus bevacizumab for patients with NSCLC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006514
Enrollment
25
Registered
2011-10-12
Start date
2011-10-01
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

non-small cell lung cancer

Interventions

irinotecan 50mg/m2 paclitaxel 180mg/m2 bevacizumab 15mg/kg every 4weeks more than 3cycles maintenance of bevacizumab until PD

Sponsors

Nagasaki Thoracic Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)non-squamou and non-small cell lung cancer with over-expression of ERCC1 2)not having homo-UGT1A1*6 and *28 3)stage IIIB or IV without indication of radiation 4)previously untreated patients without EGFR-TKIs 5)ECOG PS 0-1 6)having measurable lesions according to RECIST(version1.1) 7)adequate kidney, liver, bone marrow functions 8)expecting the survival period more than 12 weeks 9)written informed consent

Exclusion criteria

Exclusion criteria: 1)brain metastasis 2)cavity lesion 3)invasion of giant vessels 4)hemoptysis 5)history of radiotherapy for lung 6)interstitial pneumonitis 7)watery diarrhea 8)severe gastrointestinal disease 9)uncontrollable fever up 10)other sever disease 11)uncontrollable pericardial,pleural effusion and ascites 12)other carcinoma 13)sever allergy history 14)receiving anti-coagulate treatment without biaspilin 15)psychological disease 16)women with pregnant or under lactation 17)others diagnosed as inadequate case to enter the trial

Design outcomes

Primary

MeasureTime frame
response rate

Countries

Japan

Contacts

Public ContactYoichi Nakamura

Nagasaki University School of Medicine Second Department of Internal Medicine

yi-nakamu@umin.ac.jp095-819-7273

Outcome results

None listed

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