A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.

A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer. - A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005991

Enrollment

Registered

2011-07-20

Start date

2011-08-01

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-squamous non-small cell lung cancer (EGFR mutation status Negative)

Interventions

Four cycles of Pemetrexed + Carboplatin + Bevacizumab followed by maintenance Pemetrexed until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer.(EGFR mutation status negative). 2)Stage III/IV unresectable or unsuitable for radical irradiation Non-Squamous NSCLC. 3)No prior chemotherapy . 4)Measurable tumor sites 5)ECOG-PS of 0 or 1. 6)20years-old,more than 80years-old 7)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial. 8)Life expectancy more than 3 months. 9)No problem adequate organ function 10) Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan. 2)Patients with active co-morbidities including severe conditions. 1.uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease. 2.uncontrollable diabetes, hypertension. 3.severe infection 4.paresis of intestine, illeus 5.Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum 6.Great vessel involvement 7.Melena 8.Receiving anticoagulant drug 9.Uncontrolled urinari protein 10.CongenitalbleedingdiathesisCoagulation abnormalities 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor. 3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated. 4) Brain metastases with neurological symptoms. 5) Active double cancer. 6)Pregnancy, breast feeding and suspected pregnancy. 7)History of grave drug allergic reaction. 8) Psychiatric disorder. 9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.

Design outcomes

Primary

Measure	Time frame
RR: Response rate	—

Secondary

Measure	Time frame
QOL: Quality of life DCR: Disease control rate PFS: Progression free Survival OS: Overall survival AE: Adverse events	—

Countries

Japan

Contacts

Public ContactKazutoshi Isobe

Toho University Omori Medical Center respiratory medicine

kazutoshiisobe@aol.com03-3762-4151

Outcome results

None listed

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