A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer

A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer - A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006874

Enrollment

Registered

2011-12-12

Start date

2012-01-01

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

Patients were given Cisplatin (75mg/m2, div), Pemetrexed (500mg/m2, div) and Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, up to 6 courses more than 4 courses. Patients without unacceptable tox

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer 2)stage IIIB/IV or postoperative recurrence patients 3)chemotheraoy naive patients 4)Performance Status(ECOG) 0-1 5)Patient who has at least one or more measurable lesion by RECIST 6)Patients aged 20 years or older 7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less. *Total bilirubin <=1.5mg/dL. *Serum creatinin, x 1.5 of ULN or less. *Electrocardiogram Nomal *SpO2 >=90% or SaPO2 >=65mmHg *Protein urea >= 1+ 8)Patients who are considered to survive for more than 3 months. 9)interval: (1)Radiation *More than 2 weeks after the last irradiation to other organs. (2)Operation (including pleurodesis) *More than 4 weeks after the operation without Lobectomy (including exploratory surgery) *More than 2 weeks after the last operation (including pleurodesis) 10)Patients providing written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with untreated Brain metastases 2)Patients with current or previous history of hemoptysis (2.5mL or more) 3)Patients with uncontrolled hyper tension 4)Patients with uncontrolled infection 5)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis 6)Patients with uncontrollable complications 7)Patients with massive pleural or pericardial effusion,or ascites 8)Patients with active concomitant malignancy 9)Patients with previous histories of drug allergy 10)Patients with uncontrollable gastrointestinal ulceration 11)Patients with current or previous (within one year) history of gastrointestinal perforation 12)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) 13)Pregnancy or lactation 14)Inappropriate patients for this study judged by the physicians

Design outcomes

Secondary

Measure	Time frame
Progression-free survival, Overall survival, Time to Treatment Failure, Response rate, Disease control rate, Adverse events, Response rate of each EGFR status, Biomarkers	—

Primary

Measure	Time frame
Two years overall survival rate	—

Countries

Japan

Contacts

Public ContactHiroyuki Suzuki

Fukushima medical University Department of Regenerative Surgery

024-547-1111

Outcome results

None listed

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